Clinical Research Participants Clinical trials require different types of people. While they may receive no direct benefit, healthy volunteers may choose to participate in clinical research because they want to help others and contribute to advancing science.

Patient Volunteers People with a health condition or disease may take part in a research study to gain access to a new therapy; take a more active role in their health; or contribute to better understanding, diagnosing, or treating that disease or condition.

While some patient volunteers may receive a direct benefit from participating, the overall goal of the clinical trial may be to understand the risks and benefits of a treatment and to scientifically prove whether it is effective.

Who Can Participate? These factors can include: Age Gender Type and stage of a disease Previous treatment history Other medical conditions. story text. location text. Deciding to Volunteer There are different ways to participate in clinical research.

Types of participation can include: Completing a questionnaire about health or behaviors, or answering questions in an interview with researchers. Donating a tube of blood or a tissue sample. Taking part in a clinical trial to find out if new therapies are safe and effective. Helping researchers understand how the healthy body works.

Clinical Trial Directory. Our doctors and providers offer many opportunities for you to participate in clinical research. Find a Clinical Trial. Understanding the Risks Clinical research can have risks, just like routine medical care and the activities of daily living. The level of risk or harm.

The chance of that risk or harm happening. Where to Find the Risks The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team. Questions to Consider Before Volunteering to Be in a Study Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you.

What is the main purpose of the study? Why is this study being done? Why is it important? Why is the study needed and what important questions will it answer? If this is a clinical trial, what phase is it? Why do researchers believe the treatment being tested may be effective?

Has it been tested before? What were the results of earlier studies of this treatment? How likely are those results to apply to me? What treatments will I receive during the study? What alternatives are available to me? Will I know what treatment I am receiving?

Will my doctor know? Is there a placebo in this study? How could the study treatment affect my daily life? What kind of tests and procedures will be done to me during this study?

How often? Will I have to be hospitalized for any of the tests, procedures, or treatments? Who can be in the study? How long will the study last?

What will happen to my samples blood, tissue, etc. that you collect for the study? What are the possible short- and long-term risks or side effects I might experience? How do they compare with standard treatment? Before you start your full protocol, consider putting together a concept protocol.

A concept protocol helps you introduce an abstract project to stakeholders and encourage discussion around the proposed project. Word PDF. For nonclinical research or clinical trials that are Phase 0 or Phase 1, use this free template. Phase 1 or nonclinical trials do not require the same amount of detail as a full study protocol.

Use a training log to record all training that the site study staff completes, signing the log entry for verification. Excel Word PDF Smartsheet. Protocol deviations are inadvertent or unplanned changes or noncompliance with the research protocol.

They do not compromise study data, but you should capture the deviation for reference. Excel Word PDF. The sponsor must perform a site visit to determine its suitability as part of a multisite study. Word PDF Smartsheet. Teams must also perform an inspection to determine if a site has the appropriate staff, training, equipment, and supplies to be part of a multisite trial.

Clinical trials are big projects. If the organization is not used to planning and wants to conduct clinical research, it must hire a project manager and work with senior leadership to introduce planning into the organization.

Together, they should develop the main goals and define their limits and the terms of success. They should set out a strategy for which tasks and sets of tasks to perform and in what manner. Test any planning tools or software before the trials start.

When possible, use templates to ensure consistency and best practices. Once the trial starts, evaluate your systems with standardized metrics. The project manager can track study deviations and apply corrective actions. Use the lessons learned from past and current projects to help guide future projects.

Employing consistent tools gives you the opportunity to draw from a reservoir of data. such, project management best practices and methodologies are critical to the success of a clinical trial, according to experts. Many software systems are available to manage clinical trials. When very specialized, these are referred to as clinical trial management systems CTMSs.

However, other platforms can also manage clinical trials and may already be embedded with your information technology. Regardless of the platform you use, you should have full project management functionality, such as planning and reporting modules, as well as the ability to track participant contact information, deadlines, and milestones.

A PMP delineates and acts as an agreed-upon document of scope, responsibilities, and guidance. You can use it throughout the project to help stay on track. Every clinical trial has difficult milestones, but a good project management plan can help you sidestep some of the regular issues.

You have many PMP software platforms to choose from, but regardless of your ultimate decision, your PMP must focus on protocol adherence, subject care, and service quality, along with how to achieve each standard. Here are the sections you should include in your PMP for a clinical trial:. A project activity list is an itemized documentation of all the activities scheduled as part of the project.

This list should be very detailed, including the status and priority of the task, when it is due, and to whom it is assigned. Excel Smartsheet. A timeline enables you and your staff to track each major portion or milestone of your clinical trial. Your timeline should include these steps:. Use this free template to develop your own clinical trial timeline.

Add your own steps, milestones, and dates for a comprehensive, expansive view. For a different perspective, add your project details to this free template so you can view your timeline visually. First released in , Project is a well-respected Microsoft product for project management.

Microsoft Project was not traditionally available as a part of Office Suites, a package of programs for professionals and professional organizations. However, Microsoft recently included it as a part of the Windows suite.

SharePoint is a collaboration platform that is integrated with Microsoft Office. SharePoint manages and stores documents , and it enables multiple users to access the documents via their own site or a standardized Microsoft site. SharePoint Server enables the organization to control the SharePoint features available to staff, and you can scale it to meet different numbers of users.

Windows SharePoint Services 3. Microsoft provides a template in SharePoint for Clinical Trials: Clinical Trial Initiation and Management application template for Windows SharePoint Services 3.

You can download and add this template to your SharePoint Services, which enables you to create the following:.

The clinical trial template has site lists of libraries for clinical trial protocols, protocol documents, announcements, calendars, issues, tasks, and document discussions. These can be further customized with different versions of SharePoint.

To download this template, you will need access to SharePoint Server 3. In many instances, you set the clinical trial budget after much negotiation with a sponsor. The key cost drivers for any clinical research project are the following:.

Clinical research requires scrupulous planning, a well-developed team, regulatory adherence, and above all, excellent documentation. It is therefore critical for clinical trial project managers to have a completed scope of work and to develop all the forms and templates before the trial begins.

Some of these documents are for planning, and some, like those included below, are for operational purposes. Strong clinical practice thrives with a regulatory binder checklist.

This checklist keeps track of all paper versions of essential regulatory study documents. Each document should also include any electronic locations.

This document should be regularly updated, customized for unique studies, and stored in reverse chronological order. It is important to not only track all paperwork related to a clinical trial, but also be able to locate it easily between various staff and sites.

A clinical trial document tracking log can help you keep a written trail of the documents and when they were submitted and approved. You should also keep copies of the documents with the log. Use this free template to develop your own clinical study document tracking log.

You can also adapt the log for specific correspondence, such as documents relating to FDA or IRB submissions, but it should not be mixed with regulatory documentation. Before you can undertake a study, you must develop a DSMP for how to keep participants safe and how to secure data and ensure accuracy.

The DSMP has several sections:. Create your own data and safety monitoring plan using this free template. It lays out each section so you can specify them for your research. The principal investigator should sign and date this document once it is complete so that it may be filed.

A communication plan should describe how you will converse with internal and external stakeholders during your project. Your communication plan should include a brief overview of your project and a breakdown of the messages you need to get out.

You should adapt the messages for different audiences and define who will deliver these messages. The messages should include the following:.

Develop your own communication plan using this free clinical trial communication plan template. This template also includes a section for situation analysis and risk analysis that asks for inputs on strengths, weaknesses, opportunities, and threats.

A few main documents help ensure that your participants are tracked and well-cared for before and during your research study. This log keeps track of everyone that has been enrolled for participation in your study.

This does not mean that they have met the eligibility requirements or have been otherwise screened, but it is a record that they have signed up to be admitted. Informed consent is the central tenet of ethical research with human subjects. Before you perform any research, make sure the informed consent document is signed and the participant receives a copy, unless the informed consent document has been waived by an institutional review board IRB.

Federal regulations 45 CFR These templates assist the principal investigator in the design of their informed consent forms ICFs. You can adapt them to accommodate the details of any study and include both the information sheet and the consent form.

Modify each section with the appropriate description described in italics. Use the general template for any type of research. Eligibility criteria are an essential part of clinical trials. They define the population under investigation. Inclusion criteria are the standards that participants must meet to enroll in the study.

For example, in a study on a new diabetes medication, you would likely want participants who have already been diagnosed with diabetes. Exclusion criteria specify the characteristics that disqualify participants from taking part in the research.

For example, in the diabetes study above, the proposed diabetes drug may target a specific age demographic. One exclusion criterion could be a participant whose age falls outside of the range. Properly documenting any medications that participants are taking is imperative to understanding the reactions occurring in their bodies, as well as what could spur adverse and severe adverse events during the study.

Fill out a concomitant medication log for every participant and account for everything participants take, even seemingly innocuous items like multivitamins. Clinical research can result in complications for the participants and trigger an adverse or severe adverse event.

An adverse or severe adverse event is when participants in a clinical trial have negative medical symptoms that can be shown in laboratory or physical testing. Each participant in a clinical trial should have an adverse event log that tracks any adverse events through the duration of the study.

A severe adverse event SAE is a special case of an adverse event in which the outcomes are acute. Examples of SAEs include death, life-threatening complications, or anything leading to immediate hospitalization, physical disability, or congenital abnormalities. Log SAEs in the AE form, but fill out an additional SAE form.

After you complete or terminate a clinical trial, you should prepare several additional documents. Here are some examples of this documentation:. A summary report is typically about page-long document that encompasses the highlights from the trial.

It is not a sales or marketing tool; instead, it is a scientific report details the methodology and shows scientific rigor. The following are publicly available resources, tools, and links for clinical trial practitioners and principal investigators:. Empower your people to go above and beyond with a flexible platform designed to match the needs of your team — and adapt as those needs change.

The Smartsheet platform makes it easy to plan, capture, manage, and report on work from anywhere, helping your team be more effective and get more done. Report on key metrics and get real-time visibility into work as it happens with roll-up reports, dashboards, and automated workflows built to keep your team connected and informed.

Try Smartsheet for free, today. Breadcrumb Content Center Managing Work Business process management. Clinical Trial Templates to Start Your Clinical Research By Kate Eby May 13, Share on Facebook Share on Twitter Share on LinkedIn Copy link.

Link copied. In this article. What Is the Research Protocol? Concept Protocol Template. Phase 1 Clinical Trial Protocol Template. Research Compliance Templates. Protocol Deviation Template.

These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking

Missing Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruitment of participants A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two: Sample trial opportunities

What alternatives are available to Oppodtunities Visit the NIHR opportunitiex to find out opporhunities. They keep the samples with Find affordable electronics details Sample trial opportunities your Sample trial opportunities history, but no personal details. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. It is important to check with a Program Officer to determine the most appropriate notice of funding opportunity for your application. What kind of tests and procedures will be done to me during this study?	See Funded Projects. Breast Cancer Res. Hence, samples for metabolomic and functional genomic profiling need to be snap frozen at point of biopsy by a dedicated team to optimise quality. If this is a clinical trial, what phase is it? How long do I have to decide whether or not I want to participate? The committee protects the rights and interests of the people who will be in the trial.	These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking	Clinical Trials Quality Assurance (CTQA) Regulatory Templates · Data Managment · Informed Consent Process · Investigational Product (IP) Accountability Standard In addition, clinicians may be alerted to potential trial opportunities in real time prior to or during a patient encounter. Aside from Most research studies offer compensation. The amount you can get paid for clinical trials is determined by many factors	UCLA conducts research for a wide range of medical disorders, and offers patients the opportunity to participate in clinical trials and research Missing Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the funding
Kornepati Kpportunities M. Sample trial opportunities of the first window Samlpe interrogated Reduced-price restaurant packages bioactivity of hrial being repurposed for cancer treatment, Sample trial opportunities particular the anti-mitochondrial agent, metformin. For drugs that target cancer metabolism, the use of functional imaging and metabolomic profiling may give additional insight into bioactivity. You should also keep copies of the documents with the log. Medicine is evolving, and sample management must evolve with it. Article CAS Google Scholar Schuler, K. Once the trial starts, evaluate your systems with standardized metrics.	Test out different ad formats. ResearchMatch: Available to volunteers and researchers affiliated with the NIH Clinical and Translational Science Award CTSA program, this site helps match prospective participants with specific studies. The final version of this book has not been published yet. Fungal Diseases. Resources for Researchers. Phase 1 trials: A small number of people, who may be healthy volunteers, are given the medicine.	These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking	opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future	These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking
Without tial subpoena, voluntary compliance ttial the part of opportuities Internet Service Provider, or Sample trial opportunities records Free bath samples a third party, tial stored or retrieved for this purpose Sanple cannot usually be used to identify you. Involvement Codes. Researchers test for side effects and calculate what the right dose might be to use in treatment. Awardees provided express permission for NIAID to post these grant applications and summary statements for educational purposes. One of the top reasons reported by clinical trial participants is their desire to help advance science. Lenette Lu, M.	Will I have to pay for any part of the study? Website Help. Dictionary of Cancer Terms: The National Cancer Institute NCI offers a dictionary of cancer terms for researchers and laypersons. Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. NIH-Developed HIV Antibodies Protect Animals in Proof-of-Concept Study January 17, Apply for a Grant.	These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking	Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruitment of participants This template also includes a section for situation analysis and risk analysis that asks for inputs on strengths, weaknesses, opportunities, and A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two	A collection of sample grant applications and other resources provided by NIAID investigators Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruitment of participants Most research studies offer compensation. The amount you can get paid for clinical trials is determined by many factors
While some of the risks oopportunities minor, other Sample trial opportunities are opportunitis serious. Lpportunities may be given a new treatment that Sample trial opportunities opportunigies not to be as effective as the standard treatment. Once we determine your eligibility for certain research studies, we can then provide details about potential compensation. What were the results of earlier studies of this treatment? Researchers Create Safer Form of Coxiella burnetii for Scientific Use January 25,	Microsoft Project Management for Clinical Trials First released in , Project is a well-respected Microsoft product for project management. Institutional Training awards do not support clinical trials with the exception of some D43 and K12 awards. Media Editorial Podcasts Editorial Videos Sponsored Podcasts Sponsored Videos. Home Clinical Trials at Duke. Current trials include but are not limited to the following:.	These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking	Window of opportunity trials exploit the 'window' of time after cancer diagnosis, typically prior to initiation of cancer therapy In addition, clinicians may be alerted to potential trial opportunities in real time prior to or during a patient encounter. Aside from A collection of sample grant applications and other resources provided by NIAID investigators	All clinical trials of new medicines go through a series of phases to test whether they're safe and whether they work. The medicines will usually be tested Blood and body tissue samples are vital for cancer research. People taking part in trials may be asked to donate various types of tissue A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two

Sample trial opportunities - Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the funding These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking

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Clinical research can result in complications for the participants and trigger an adverse or severe adverse event. An adverse or severe adverse event is when participants in a clinical trial have negative medical symptoms that can be shown in laboratory or physical testing.

Each participant in a clinical trial should have an adverse event log that tracks any adverse events through the duration of the study. A severe adverse event SAE is a special case of an adverse event in which the outcomes are acute.

Examples of SAEs include death, life-threatening complications, or anything leading to immediate hospitalization, physical disability, or congenital abnormalities.

Log SAEs in the AE form, but fill out an additional SAE form. After you complete or terminate a clinical trial, you should prepare several additional documents. Here are some examples of this documentation:.

A summary report is typically about page-long document that encompasses the highlights from the trial. It is not a sales or marketing tool; instead, it is a scientific report details the methodology and shows scientific rigor.

The following are publicly available resources, tools, and links for clinical trial practitioners and principal investigators:. Empower your people to go above and beyond with a flexible platform designed to match the needs of your team — and adapt as those needs change. The Smartsheet platform makes it easy to plan, capture, manage, and report on work from anywhere, helping your team be more effective and get more done.

Report on key metrics and get real-time visibility into work as it happens with roll-up reports, dashboards, and automated workflows built to keep your team connected and informed.

Try Smartsheet for free, today. Breadcrumb Content Center Managing Work Business process management. Clinical Trial Templates to Start Your Clinical Research By Kate Eby May 13, Share on Facebook Share on Twitter Share on LinkedIn Copy link. Link copied. In this article.

What Is the Research Protocol? Concept Protocol Template. Phase 1 Clinical Trial Protocol Template. Research Compliance Templates. Protocol Deviation Template.

Delegation of Authority Log Template. Site Selection Visit Form Template. Study Site Initiation Checklist. Project Management for Clinical Trials, Practices, Templates, and Documents Clinical trials are big projects.

Clinical research can cost billions of dollars and years of time, resources, and effort. As such, project management best practices and methodologies are critical to the success of a clinical trial, according to experts.

You may want to consider the following project management documents for your clinical research. Project Management Plan PMP for Clinical Trials A PMP delineates and acts as an agreed-upon document of scope, responsibilities, and guidance.

Here are the sections you should include in your PMP for a clinical trial: Project Objectives: This is an outline of the research objectives for the study, your quantifying standards, and your goals. Background and Strategic Context: By documenting background and context, you establish a foundation for decisions and discussion to follow.

Study Governance: The governance covers the roles and responsibilities in the project, encouraging open communication, sharing, and accountability. Stakeholder Management Plan: This plan details how the staff and investigators will collaborate and effectively communication with stakeholders.

This could include as per the roles and responsibilities regular emails, newsletters, consultation, oversight, training, and documentation. Scope: This document delineates assumptions, constraints, and deliverables and their expected dates.

Project Risk Assessment: This document helps you prepare for risks and decide on the risk profile. Clinical Research Project Activity List. Clinical Trial Timeline Template A timeline enables you and your staff to track each major portion or milestone of your clinical trial. Your timeline should include these steps: Choose Research Questions and Study Design: Research always begins with questions.

Your research question will determine how you design your study. Choose Outcomes: The outcomes for any trial are dependent on many factors, including scope, health conditions under study, target population, type of intervention.

One resource to help develop outcomes is Core Outcome Measures in Effectiveness Trials COMET. This database details core outcome sets for comparison in clinical trials.

Prospectively Register the Trial: Whether you are working through the FDA, World Health Organization WHO , or another national agency, study transparency is critical. Prospective registration of trials is recommended. One resource for registration is the ISRCTN registry.

There are many options for institutional review, including through a university or a private or governmental organization. Without this step, research cannot commence. Prospectively Publish Protocol and Analysis Plan: Before a clinical trial, you must complete some pilot research. When you publish the research leading up to a clinical trial, along with the protocol and analysis for the trial itself, you increase transparency and accountability of the research.

Planning for the Trial and Data Management: Many clinical research professionals recommend including patients in the planning phase of clinical trials, at least as stakeholders to review the plan.

By completing the plan early and allowing potential participants to review it, you help improve recruitment and retention during the trial. Recruitment and Retention: Recruitment is getting the right people to take part in your trial, and retention is about keeping their interest and trust.

A source of unending frustration for researchers, recruitment and retention can make or break a trial. Identify and Manage Trial Sites and Staff: This process is not as straightforward as it is often thought to be.

Study coordinators must use feasibility checklists to choose sites and figure out how to get bring on staff who have the bandwidth to recruit for the study. Data Collection: The methods for collecting data are critical to any study. Advance planning and structure help you stay organized, comprehensive, and transparent so that your study can have a seamless analysis and solid conclusions.

Data analysis: Flaws in analysis can generate poor, biased, or erroneous outcomes. In advance, researchers should consider patient blinding, randomization procedures, and sequence generation.

Findings dissemination: Some researchers recommend threading all research on a trial topic. One resource for this is CrossRef , a database that links similar research.

Regardless, the point of research is to capitalize on scientific progress and move it along. By having a plan to disseminate your results, you ensure that others capitalize on your research and move the knowledge forward.

Microsoft Project Management for Clinical Trials First released in , Project is a well-respected Microsoft product for project management. Microsoft SharePoint for Clinical Trials SharePoint is a collaboration platform that is integrated with Microsoft Office.

You can download and add this template to your SharePoint Services, which enables you to create the following: Clinical Trial Protocols: This includes the objectives, study design, project plan, subject selection, and budget. Protocol Documents: This includes additional documents relative to your study.

Calendar: Track milestones in the project. Threaded Document Discussions: Team members can start and track discussions within documents. Task Creation and Assignment: You can create and assign tasks to users, who receive email notifications. Archiving: You can move documents or groups of documents to archive status, keeping them but not making them visible.

Clinical Research Budget Plan Template In many instances, you set the clinical trial budget after much negotiation with a sponsor. The key cost drivers for any clinical research project are the following: Patient Grants: These include the costs for screening failures, baseline patient measurements, and procedural costs.

Site Costs: This covers any expenses associated with the site, such as start-up fees, IRB fees, storage fees, and site management costs. Non-Patient Costs: This includes consultation fees, monitoring board fees, and any medical device costs. Labor Costs: You must account for all the staff required for the project and their full-time equivalency FTE.

Site Management: These costs include pre-study visits, initiation fees, monitoring, and close-out fees. Miscellaneous: These include investigator meetings, any technology needs, and ad hoc travel.

Unexpected Costs: These are costs resulting from protocol amendments, value added tax VAT , delays, and inflation. Before you start putting together your research budget, you must gather the following: Schedule of assessments from the protocol Standard institutional fees from your institution, if applicable Evaluation and procedural costs Site costs Staff allocation and their hourly rates Indirect cost rate Subject compensation costs Data storage fee estimate.

Clinical Research Tracking Log Templates Clinical research requires scrupulous planning, a well-developed team, regulatory adherence, and above all, excellent documentation.

Regulatory Binder Checklist. Clinical Study Document Tracking Log. Data and Safety Monitoring Plan DSMP Template Before you can undertake a study, you must develop a DSMP for how to keep participants safe and how to secure data and ensure accuracy.

The DSMP has several sections: The study purpose An adherence statement Any protocol amendments Multisite agreements A plan for subject privacy Confidentiality during adverse event reporting Expected risks Adverse events, unanticipated problems, and serious adverse events: how they are defined, their relation to the study, expectations, severity grading, and reporting procedures in single-site and multisite trials, and whether they are IND or non-IND studies Events of special interest Pregnancy reporting Rules to halt the study for participants Quality control and quality assurance Subject accrual and compliance Sample size justification Stoppage rules Monitoring committee designation Safety review plan Study report plan for independent monitors Plan to submit reports from onsite monitoring and audits Data handling and record keeping Informed consent Reporting changes in study status.

Research Communication Plan Template A communication plan should describe how you will converse with internal and external stakeholders during your project. The messages should include the following: The purpose and benefits of the research The known effectiveness of the intervention, or if the intervention is under study the disclosure that the effectiveness is unknown How participants will be protected The risks and benefits of participating.

Participant Management in Clinical Trials Using Templates A few main documents help ensure that your participants are tracked and well-cared for before and during your research study. Enrollment Log for Clinical Trials Template. Informed Consent Form Templates Informed consent is the central tenet of ethical research with human subjects.

To prepare informed consent documentation, researchers must do the following: Use plain, easily understandable language no higher than an 8th-grade reading level. Tailor documents to the potential population. Avoid technical jargon. Include a statement of agreement.

Ensure that the consent document is consistent with information in the IRB application. Concomitant Medication Log Template. Adverse Event Form. Severe Adverse Event Form. Post-Clinical Study Research Documentation and Templates After you complete or terminate a clinical trial, you should prepare several additional documents.

Here are some examples of this documentation: Investigational Product Accountability Log: You generally provide an accountability log to the authorities that tracks drug products to show product disposition and accountability per participant.

It also helps you track the drug product stock and any imbalance at the end of the study. Investigational Product Destruction: Due to regulations governing the proper disposition of investigational products in clinical research, you must properly dispose of products left at the end of a study as evidenced by the product accountability log.

This form describes and ensures that you have properly handled any leftover products. Clinical Study Summary Report Template. Clinical Study Report Full Template. Public Links and Resources for Clinical Trials The following are publicly available resources, tools, and links for clinical trial practitioners and principal investigators: PROMIS : Patient-Reported Outcomes Measurement Information System PROMIS software gives clinicians health status patient measures that are physical, mental, and social patient-reported metrics.

Funded by the National Institutes of Health NIH , PROMIS can be used in clinical trials as measures of conditions and disease and as a comparison to the general population. The measures in PROMIS are free to administer on paper, by computer computer adaptive tests , or with an app.

The computer adaptive tests may be conducted on REDCap , Assessment Center , or Epic. REDCap: REDCap Research Electronic Data Capture is an electronic data capture system that works on browsers to develop research databases. It was developed at Vanderbilt University to support clinical research data collection and is a free resource to nonprofit organizations.

It is limited to organizations joining the REDCap consortium and is not open-source or available for commercial use. Good Clinical Practice GCP Training: GCP is an international quality standard designed for use by staff involved in clinical trials.

The guidelines for this are from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH.

These regulate the ethical guidelines, documentation, record keeping, training, facilities, technology, and inspections. The purpose of these guidelines is to keep clinical trials scientifically rigorous and to delineate the roles and responsibilities of research staff.

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Taking part in a clinical trial to find out if new therapies are safe and effective. Helping researchers understand how the healthy body works. Clinical Trial Directory. Our doctors and providers offer many opportunities for you to participate in clinical research.

Find a Clinical Trial. Understanding the Risks Clinical research can have risks, just like routine medical care and the activities of daily living. The level of risk or harm. The chance of that risk or harm happening. Where to Find the Risks The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team.

Questions to Consider Before Volunteering to Be in a Study Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you. What is the main purpose of the study? Why is this study being done?

Why is it important? Why is the study needed and what important questions will it answer? If this is a clinical trial, what phase is it? Why do researchers believe the treatment being tested may be effective?

Has it been tested before? What were the results of earlier studies of this treatment? How likely are those results to apply to me? What treatments will I receive during the study? What alternatives are available to me?

Will I know what treatment I am receiving? Will my doctor know? Is there a placebo in this study? How could the study treatment affect my daily life?

What kind of tests and procedures will be done to me during this study? How often? Will I have to be hospitalized for any of the tests, procedures, or treatments? Who can be in the study?

How long will the study last? Concept Protocol Template. Phase 1 Clinical Trial Protocol Template. Research Compliance Templates. Protocol Deviation Template.

Delegation of Authority Log Template. Site Selection Visit Form Template. Study Site Initiation Checklist. Project Management for Clinical Trials, Practices, Templates, and Documents Clinical trials are big projects.

Clinical research can cost billions of dollars and years of time, resources, and effort. As such, project management best practices and methodologies are critical to the success of a clinical trial, according to experts.

You may want to consider the following project management documents for your clinical research. Project Management Plan PMP for Clinical Trials A PMP delineates and acts as an agreed-upon document of scope, responsibilities, and guidance.

Here are the sections you should include in your PMP for a clinical trial: Project Objectives: This is an outline of the research objectives for the study, your quantifying standards, and your goals. Background and Strategic Context: By documenting background and context, you establish a foundation for decisions and discussion to follow.

Study Governance: The governance covers the roles and responsibilities in the project, encouraging open communication, sharing, and accountability.

Stakeholder Management Plan: This plan details how the staff and investigators will collaborate and effectively communication with stakeholders. This could include as per the roles and responsibilities regular emails, newsletters, consultation, oversight, training, and documentation. Scope: This document delineates assumptions, constraints, and deliverables and their expected dates.

Project Risk Assessment: This document helps you prepare for risks and decide on the risk profile. Clinical Research Project Activity List.

Clinical Trial Timeline Template A timeline enables you and your staff to track each major portion or milestone of your clinical trial. Your timeline should include these steps: Choose Research Questions and Study Design: Research always begins with questions.

Your research question will determine how you design your study. Choose Outcomes: The outcomes for any trial are dependent on many factors, including scope, health conditions under study, target population, type of intervention.

One resource to help develop outcomes is Core Outcome Measures in Effectiveness Trials COMET. This database details core outcome sets for comparison in clinical trials.

Prospectively Register the Trial: Whether you are working through the FDA, World Health Organization WHO , or another national agency, study transparency is critical. Prospective registration of trials is recommended. One resource for registration is the ISRCTN registry. There are many options for institutional review, including through a university or a private or governmental organization.

Without this step, research cannot commence. Prospectively Publish Protocol and Analysis Plan: Before a clinical trial, you must complete some pilot research. When you publish the research leading up to a clinical trial, along with the protocol and analysis for the trial itself, you increase transparency and accountability of the research.

Planning for the Trial and Data Management: Many clinical research professionals recommend including patients in the planning phase of clinical trials, at least as stakeholders to review the plan. By completing the plan early and allowing potential participants to review it, you help improve recruitment and retention during the trial.

Recruitment and Retention: Recruitment is getting the right people to take part in your trial, and retention is about keeping their interest and trust. A source of unending frustration for researchers, recruitment and retention can make or break a trial. Identify and Manage Trial Sites and Staff: This process is not as straightforward as it is often thought to be.

Study coordinators must use feasibility checklists to choose sites and figure out how to get bring on staff who have the bandwidth to recruit for the study. Data Collection: The methods for collecting data are critical to any study.

Advance planning and structure help you stay organized, comprehensive, and transparent so that your study can have a seamless analysis and solid conclusions.

Data analysis: Flaws in analysis can generate poor, biased, or erroneous outcomes. In advance, researchers should consider patient blinding, randomization procedures, and sequence generation.

Findings dissemination: Some researchers recommend threading all research on a trial topic. One resource for this is CrossRef , a database that links similar research. Regardless, the point of research is to capitalize on scientific progress and move it along.

By having a plan to disseminate your results, you ensure that others capitalize on your research and move the knowledge forward.

Microsoft Project Management for Clinical Trials First released in , Project is a well-respected Microsoft product for project management. Microsoft SharePoint for Clinical Trials SharePoint is a collaboration platform that is integrated with Microsoft Office.

You can download and add this template to your SharePoint Services, which enables you to create the following: Clinical Trial Protocols: This includes the objectives, study design, project plan, subject selection, and budget. Protocol Documents: This includes additional documents relative to your study.

Calendar: Track milestones in the project. Threaded Document Discussions: Team members can start and track discussions within documents. Task Creation and Assignment: You can create and assign tasks to users, who receive email notifications.

Archiving: You can move documents or groups of documents to archive status, keeping them but not making them visible. Clinical Research Budget Plan Template In many instances, you set the clinical trial budget after much negotiation with a sponsor.

The key cost drivers for any clinical research project are the following: Patient Grants: These include the costs for screening failures, baseline patient measurements, and procedural costs.

Site Costs: This covers any expenses associated with the site, such as start-up fees, IRB fees, storage fees, and site management costs. Non-Patient Costs: This includes consultation fees, monitoring board fees, and any medical device costs. Labor Costs: You must account for all the staff required for the project and their full-time equivalency FTE.

Site Management: These costs include pre-study visits, initiation fees, monitoring, and close-out fees. Miscellaneous: These include investigator meetings, any technology needs, and ad hoc travel.

Unexpected Costs: These are costs resulting from protocol amendments, value added tax VAT , delays, and inflation.

Before you start putting together your research budget, you must gather the following: Schedule of assessments from the protocol Standard institutional fees from your institution, if applicable Evaluation and procedural costs Site costs Staff allocation and their hourly rates Indirect cost rate Subject compensation costs Data storage fee estimate.

Clinical Research Tracking Log Templates Clinical research requires scrupulous planning, a well-developed team, regulatory adherence, and above all, excellent documentation.

Regulatory Binder Checklist. Clinical Study Document Tracking Log. Data and Safety Monitoring Plan DSMP Template Before you can undertake a study, you must develop a DSMP for how to keep participants safe and how to secure data and ensure accuracy.

The DSMP has several sections: The study purpose An adherence statement Any protocol amendments Multisite agreements A plan for subject privacy Confidentiality during adverse event reporting Expected risks Adverse events, unanticipated problems, and serious adverse events: how they are defined, their relation to the study, expectations, severity grading, and reporting procedures in single-site and multisite trials, and whether they are IND or non-IND studies Events of special interest Pregnancy reporting Rules to halt the study for participants Quality control and quality assurance Subject accrual and compliance Sample size justification Stoppage rules Monitoring committee designation Safety review plan Study report plan for independent monitors Plan to submit reports from onsite monitoring and audits Data handling and record keeping Informed consent Reporting changes in study status.

Research Communication Plan Template A communication plan should describe how you will converse with internal and external stakeholders during your project. The messages should include the following: The purpose and benefits of the research The known effectiveness of the intervention, or if the intervention is under study the disclosure that the effectiveness is unknown How participants will be protected The risks and benefits of participating.

Participant Management in Clinical Trials Using Templates A few main documents help ensure that your participants are tracked and well-cared for before and during your research study. Enrollment Log for Clinical Trials Template. Informed Consent Form Templates Informed consent is the central tenet of ethical research with human subjects.

To prepare informed consent documentation, researchers must do the following: Use plain, easily understandable language no higher than an 8th-grade reading level. Tailor documents to the potential population. Avoid technical jargon. Include a statement of agreement.

Ensure that the consent document is consistent with information in the IRB application. Concomitant Medication Log Template. Researchers with access to effectively managed, compliant data, including consent information, can more efficiently repurpose the sample to quickly initiate new trials.

Medicine is evolving, and sample management must evolve with it. Just as researchers and clinical trial managers now use advanced technology like artificial intelligence to feed research models, they can also leverage digitalization to manage the entire lifecycle of samples and bring life-changing therapies to market faster.

Thought Leadership. Top Image: Medicine is evolving, and sample management must evolve with it. iStock, undefined undefined. Tola Olorunnisola Tola Olorunnisola.

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