Clinical Research Study Investigator’s Toolbox

Supporting Clinical Research

The purpose of the NIA Clinical Research Toolbox is to provide a Web-based informational repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations and informational materials to assist investigators in the development and conduct of high quality clinical research studies.

Note: NIA is refreshing the entirety of the NIA Clinical Research Toolbox. Check back for updates.

Pre-Award

Data Safety and Monitoring

As depicted in the NIA Guidance on Clinical Trials , NIA is responsible for overseeing the data and safety monitoring of the clinical research it supports. Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants and with the size and complexity of the study.

Applicants requesting support for any intervention study must complete "PHS Human Subjects and Clinical Trials Information" form of the SF424 (R&R), describe a data and safety monitoring plan (DSMP), which discusses the need for an independent data and safety monitoring body or justifies why such a body is not needed to monitor the study and proposes an alternative safety monitoring mechanism. For example, for a single-site, low risk study, the PI may propose a local safety monitor, while a multi-site, higher risk study might propose a Data and Safety Monitoring Board (DSMB).

Data Sharing

The National Institutes of Health (NIH) advocates making available to the public the results and accomplishments of the activities that it funds. NIH assures that research resources developed with public funds become readily available to the broader research community in a timely manner for further research, development, application, and secondary data analysis. The expectation is that this will lead to products and knowledge of benefit to public health. To ensure that future research can build on previous efforts and discoveries, the National Institutes of Health (NIH) has developed a data sharing policy effective October 1, 2003, for applicants seeking NIH funding of $500,000 or more in direct costs in any one year. The policy expects final research data, especially unique data, from NIH-supported research efforts be made available to the investigators. The NIH policy on data sharing applies to:

  • Basic research, clinical studies, surveys, and other types of research supported by the NIH.
  • Human subjects and laboratory research.
  • Data not produced with NIH funding but used in an NIH-supported activity in some instances.

Investigators are expected to include in their grant application a brief description of how final research data will be shared, or explain why data-sharing is not possible (for example: human subject protection concerns). Please see NIH’s

(MS Word, 55K) for a template you may modify to fit the data you plan to share.

(MS Word, 39K) - This form should be used to advocate for an initiative by the Division of Geriatrics and Clinical Gerontology (DGCG) for a clinical trial or trials that exceed $2 million in direct costs in any year of funding. DGCG Clinical Trials Advisory Panel, a task force of the National Advisory Council on Aging (NACA), will evaluate the concept proposals in October – November of each Fiscal Year and will provide its recommendations to DGCG, NACA, and to the NIA Director on initiatives for large clinical trials.

Back to top

Study Startup

Protocol

The clinical protocol is a document that describes how a clinical study will be conducted by detailing the objective(s), design, methodology, statistical considerations and organization of a clinical study, and describes methods used to ensure the safety of the study participants and integrity of the data collected.

(MS Word, 88K) - The Clinical Intervention Study Protocol Template outlines a clinical study protocol and provides guidance on important content to include in each section. The template can be downloaded as an MS Word file for adaptation by the study investigator.

Manual of Procedures

A Manual of Procedures (MOP) is a handbook that details a study’s conduct and operations as well as facilitates consistency in protocol implementation and data collection across study participants and sites. It operationalizes the study protocol and describes each step of the study and how it is to be executed. A copy of the MOP should be provided to each member of the Study Team. Ideally, the MOP would contain an adequate amount of detail that any individual(s) at any site(s) could run the study consistently with only the information contained in the MOP and its appendices.

Get resources to support your study recruitment

Visit NIA’s ADORE (Alzheimer’s and Dementia Outreach, Recruitment, and Engagement) Resources for a searchable collection of materials for clinical trials recruitment and retention.

The NIA recognizes the importance of a MOP and has developed documents to assist principal investigators in writing their study MOP. Investigators with a multi-site study are required to submit a MOP, while single-site study investigators are strongly encouraged to review the MOP and determine which sections are necessary in order to ensure the study procedures are performed as intended. The Guidelines below provide details on each section of the MOP, while the MOP Outlines are an overview listing the sections that are most relevant in those types of studies.

The following documents can also be found within the MOP template:

  • Schedule of Events presents the activities that take place at each contact with the participant.
  • Protocol Deviation Log provides participant-specific documentation of missed visits and other actions that deviate from the protocol.

Back to top

Informed Consent

The consent process provides individuals with sufficient information for making informed decisions about participation in a clinical research study. The following documents are provided as a tool to assist NIA investigators for developing a comprehensive informed consent:

Back to top

Data Safety and Monitoring Boards

The Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises the NIA Director and the study investigators. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations. The need for DSMB oversight is based on assessment of the study’s overall risk. Investigators may propose a DSMB in their grant application, or NIA may require that a DSMB be established following consideration of review panel’s comments, NIA’s National Advisory Council on Aging (NACA) advice, and/or input from NIA staff.

Additional Startup Tools

  • (MS Word, 30K) help to ensure adequate data management processes and procedures in a clinical study. Investigators are encouraged to use Data Management Tips to describe how data will be handled in the study.
  • Best Practices for Data Coordinating Centers – This Compendium, developed by the National Heart Lung and Blood Institute (NHLBI) provides helpful tips for clinical researchers and other stakeholders for developing large, multisite clinical trial programs.

Back to top

Recruitment and Retention Resources

The NIA Clinical Research Toolbox includes a broad array of resources to support communications, training, recruitment, engagement and more. Learn about research and retention resources below.

Communicating with Participants, Staff, and Community Partners

A collection of outreach, recruitment, and engagement resources providing tips and strategies for communicating with potential clinical trial participants.

​ ADORE (Alzheimer’s & Dementia Outreach, Recruitment & Engagement Resources) ​
An NIA repository of resources to support the recruitment and retention of participants into clinical trials and studies on Alzheimer’s disease and related dementias. ​

Alzheimer’s and Dementia Information to share with Participants ​
NIA resources for caregivers and people living with dementia.​

Engagement and Access for Research-Active Institutions (EARA) ​
Resource from the Office of the Director is a communication tool focused on outreach to research-active institutions and NIH institutes, centers, and offices.​

Guidance regarding social media tools ​
Developed by the NIH Office of Intramural Research and provides best practices when using social media tools and new technologies to recruit for clinical trials.​

Providing Care to a Diverse Older Adult Population ​
An NIH resource on communicating with a diverse older patient population with tips for culturally sensitive care.​

Recruiting and Communicating with Participants ​
NCCIH presents strategies about how to be thoughtful about participants, staff, and community partners with emphasis on good communication skills and habits. ​

Talking to Your Patient About a Clinical Trial ​
NIH provides communication guidance in the form of a modified checklist for talking to patients about clinical trials. ​

Talking With Older Patients ​
NIH shares tips for communicating with older patients, including families and caregivers as part of the health care team, obtaining a thorough history from participants, discussing medical conditions and treatments, confusion and cognitive problems, and sensitive topics.​

Engagement and Recruitment Planning Resources

Resources related to clinical trials planning, recruitment, and engagement.


A resource developed by the NIA that outlines strategies for clinical research recruitment.

Accrual Stages
An NCCIH resource on the five stages of study development including: Developing a Study; Selecting & Preparing to Open a Study; Recruiting and Communicating with Participants; Implementing the Study; and Evaluating Accrual and Reporting Lessons Learned.

National Strategy for Recruitment and Participation in Alzheimer's and Related Dementias Clinical Research
Published by the NIH and NIA, the National Strategy is designed to engage broad segments of the public in Alzheimer’s and related dementias research.

OutreachPro
NIA developed a free online recruitment materials generator for researchers and research teams to create customizable outreach materials. OutreachPro has a library of content designed specifically for African American, Hispanic/Latino, Asian American and Pacific Islander populations and available in English, Spanish, Simplified Chinese, Tagalog and Hindi. Explore the OutreachPro video playlist for videos on clinical trial participants, caregivers, and the benefits of participating in clinical research.

Recruiting & Communicating with Participants
An NCCIH resource to engage intermediaries to aid in accrual to clinical research:

Recruitment & Retention Planning: Getting Started
Resources and tips from NINDS to create a recruitment and retention plan while you are writing the grant proposal and study protocol.

  • Identify potentially eligible participants
  • Engage participants in the Informed Consent Process
  • Consider participant financial issues
  • Maintain the morale and interest of staff, participants and their families
  • Update participants regarding study related events and results

Inclusion and Disparities

A collection of recruitment and retention resources focused on health disparities and inclusion of underrepresented populations.

CEAL (Community Engagement Alliance)
CEAL is an NIH research network designed to work with communities and community-based organizations to identify promising engagement and outreach practices that communicate trustworthy, science-based information to communities experiencing health disparities.

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
This guidance provides FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies.

Community Health Disparities Recruitment
From NHLBI, this Community Health Toolkit was designed to assist in planning, running, and evaluating programs and includes recruiting scenarios and informational handouts.

Cultural Competence
Resources from across NIH are presented for researchers to consider regarding importance of cultural competence to promote effective and culturally informed recruitment and retention strategies.

Enhancing the Diversity of Clinical Trial Populations
This FDA guidance recommends approaches that sponsors of clinical trials can take to increase enrollment of underrepresented populations in their clinical trials.

Health Disparities Framework
This NIA page is designed to serve as a resource for scientists interested in investigating health disparities related to aging. It lists the priorities in aging research.

Health Equity Guiding Principles for Inclusive Communication
The CDC provides guidance for health communicators to ensure their communication products and strategies adapt to the specific cultural, linguistic, environmental, and historical situation of each population or audience of focus.

NIH Inclusion Policies for Research Involving Human Subjects ​
NIH is committed to supporting clinical research that benefits individuals of all sexes/genders, races, ethnicities, and ages. The information provided on this website is designed to assist the extramural community in addressing inclusion, including the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy, in NIH grant applications and progress reports.

Primary Barriers and Facilitators to Participation in Clinical Research
The Office of Research on Women's Health at NIH provides a summary of the literature on the barriers and facilitators to recruiting from diverse backgrounds to clinical trials.

Recruitment and Retention of Women in Clinical Research
NIH Inclusion Outreach Toolkit on how to engage, recruit, and retain women in clinical research with strategies that are relevant to women and translatable across many subgroups of the U.S. population. This toolkit also includes case studies that highlight effective recruitment practices.

Information for Participants

A collection of resources to help individuals learn more about clinical research, and find available clinical trials by location, condition, and intervention.

NIA Clinical Trials and Studies
An NIA resource providing a variety of articles for potential clinical trial participants.

NIH Clinical Research Trials and You
An NIH resource for people who want to learn more about clinical trials. It includes commonly asked questions and responses about participating in a clinical trial.

ClinicalTrials.gov
An online database of clinical research studies that provides information about clinical research studies to the public, researchers, and health care professionals. Visit the Learn About Studies page to learn more.

Find Clinical Trials
Tool for the public to find Alzheimer’s and related dementias clinical trials by location.

Personal Stories About Alzheimer’s and Related Dementias Research
Watch English videos from clinical trials participants or Spanish videos from clinical trials participants .

ResearchMatch
An NIH funded nonprofit program that helps to connect people interested in research studies with researchers from top medical centers across the US.

“Why I Participate” Videos
From the NIA YouTube channel, this playlist contains videos of caregivers and those who are at risk for Alzheimer’s disease.

General Resources

Plainlanguage.gov
A resources design to help teams communicate in a way that their audience can understand the first time they read or hear it.

OutreachPro
NIA developed a free online recruitment materials generator for researchers and research teams to create customizable outreach materials. OutreachPro has a library of content designed specifically for African American, Hispanic/Latino, Asian American and Pacific Islander populations and available in English, Spanish, Simplified Chinese, Tagalog, and Hindi. Explore the OutreachPro video playlist for videos on clinical trial participants, caregivers, and the benefits of participating in clinical research.

Recruitment Innovation Center (RIC)
Advice, guidance and recommendations about community engagement, recruitment planning and feasibility assessment, recruitment materials, EHR-based cohort assessments, and expression of interest.

Community Informed Recruitment and Retention Template
A tool to assist research teams in achieving recruitment and retention goals of historically underrepresented racial and ethnic populations.

Back to top

Safety

Investigators must include in their application proposed adverse event (AE) and serious adverse event (SAE) definitions and discuss their monitoring and reporting. All clinical trials of drugs and biological products conducted under an Investigational New Drug Application (IND) must use definitions of adverse events and adverse reactions and follow the reporting requirements established by 21 Code of Federal Regulations (CFR) Part 312.32. Trials of medical devices conducted under an Investigational Device Exemption (IDE) must use the definitions and reporting requirements established by 21 CFR 812. All other interventional studies must propose their definitions of adverse events and their reporting procedures. See the NIA Guidance on Clinical Trials for additional information.

The NIA Safety Training Course (available below), an online training venue, provides an overview of human subject safety surveillance and reporting requirements in clinical research studies. The intent of the course is to help clinical study investigators and staff understand and implement NIA and regulatory requirements for safe, high quality clinical research. The topics covered include Good Clinical Practice (GCP), Human Subject Protections, Adverse Events and Unanticipated Problems, Safety Monitoring and Reporting Requirements, Safety Monitoring and Oversight: Data and Safety Monitoring Boards (DSMBs) and Safety Officers, Regulatory Requirements and Responsibilities of Principal Investigators, and Data and Safety Monitoring Plans. The course requires about 40 minutes to complete.

Back to top

Forms and Templates

Administrative Forms

(MS Excel, 22K) Provides documentation of all individuals who were evaluated for participation in a research study. The log typically contains a unique identification number for each person screened along with individuals’ date of birth, sex, race and ethnicity, screening, and eligibility status.

Site Signature Log - Delegation of Authority Log (

or ) A record of all study personnel and their specific responsibilities, signatures, and dates of involvement during the conduct of a clinical research study.

(MS Word, 20K) – Used by clinical site staff to document protocol deviations or other discrepancies identified during the conduct of the clinical research study and plans for resolution/prevention.

(MS Word, 25K) – The visit schedule tracks an individual participant’s progress through the study and helps to ensure that visits take place during the protocol-specified timeframe. The visit flow provides an overview of the activities that take place at each study visit, and may be customized for each study site.

(MS Excel, 12K) – Used to track study drug/investigational product disposition and accountability by the clinical research site. For multi-site studies under an investigational new drug (IND) application, this tracker could be used by coordinating centers to track the overall distribution of investigational product.

(MS Word, 30K) – Used to track study drug/investigational product disposition and accountability for each individual participant. This form may be used to track protocol adherence via amount dispensed and returned and is designed to be used in conjunction with the Study Drug/Investigational Product Tracker. May also be used to track study drug/investigational return or destruction.

Study-wide Forms

Adverse Events Form (

or )

Prior and Concomitant Medications (

or )

Protocol Deviations Form (

or )

Serious Adverse Events Form (

or )

Study Disposition Form (

or )

Baseline Visit Forms

Visit Checklist (

or )

Eligibility Form (

or )

Demographics Form (

or )

Medical History Form (

or )

Medical History Conventional (

or )

Vital Signs Form (

or )

Physical Exam Form (

or )

Randomization and Enrollment Form (

or )

Back to top

Clinical researcher with older patient