Clinical Research Study Investigator's Toolbox
Protocol (MS Word, 93K) - The Clinical Intervention Study Protocol Template outlines a clinical trial 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 (MOP) - A 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 transforms the study protocol into a guideline that 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 an individual(s) at all site(s) could run the study consistently with only the information contained in the MOP and its appendices.
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.
- Manual of Procedures (MOP) Outline – Multi-Site (MS Word, 30K)
- Manual of Procedures (MOP) Guidelines – Multi-Site (MS Word, 179K)
- Manual of Procedures (MOP) Outline – Single-Site (MS Word, 27K)
- Manual of Procedures (MOP) Guidelines - Single-Site (MS Word, 170K)
The following documents can also be found within the MOP template:
- Screen Log 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’ initials, age, gender, race and ethnicity, screening date, and eligibility status.
- 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.
Recruitment and Retention Tips (MS Word, 33K) describe approaches to recruitment and retention of older individuals from diverse ethnic and racial groups in clinical research studies.
The NIA Safety Training Course (available below), an online training venue, provides an overview of human subjects 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.
Data Management Tips (MS Word, 30K) help to ensure adequate data management processes and procedures in a clinical trial. Investigators are encouraged to use Data Management Tips to describe how data will be handled in the study.
Initial Proposal Concept Form (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.
Best Practices for Data Coordinating Centers – This Compendium, developed by the National Heart Lung and Blood Institute, NIH, provides helpful tips for clinical researchers and other stakeholders for developing large, multisite clinical trial programs.
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 to 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.
Please see NIH’s Example Plan (MS Word, 55K)for a template you can modify to fit the data you plan to share.