Clinical Research Study Investigator's Toolbox
The purpose of the NIA Clinical Research Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies.
Protocol (MS Word, 185K) - 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) (MS Word, 369K) - A MOP facilitates consistency in protocol implementation and data collection across study participants and sites. The template describes each section that is typically included in a multi-center study MOP. The scope of tasks and responsibilities outlined for the conduct of a clinical trial are useful for investigators of single-site studies.
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, 46K) describe approaches to recruitment and retention of older individuals from diverse ethnic and racial groups in clinical research studies.
Adverse Events (AEs) and Serious Adverse Events (SAEs) Guidelines (MS Word, 62K) describe requirements and processes for reporting adverse events and unanticipated problems to the study's safety monitoring bodies. It incorporates guidelines provided by the Office of Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS) and describes Food and Drug Administration (FDA) reporting requirements.
- Adverse Event Form (MS Word, 38K or screen-readable PDF, 69K) provides a template for a study form for collecting information about adverse events that is reviewed by safety monitoring bodies.
- Serious Adverse Event Form (MS Word, 51K or screen-readable PDF, 99K) provides a template for a study form for collecting information about serious adverse events. The form includes major components of the Food and Drug Administration (FDA) Form 3500.
- AE/SAE Process Flow (MS Word, 79K or screen-readable plain text file, 4K) illustrates how adverse events and serious adverse events are handled within a study.
Data and Safety Monitoring - As depicted in Implementation of Policies for Human Intervention Studies, NIA is responsible for overseeing the data and safety monitoring 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.
- All clinical trials require study-specific monitoring procedures to ensure participant safety and data integrity. The following templates were developed to assist investigators in meeting this goal. The Data and Safety Monitoring Plan (DSMP) outlines procedures that investigators and study staff will follow when implementing a clinical trial. Investigators submitting grant applications for clinical trials are required to include a general description of the DSMP as part of the research grant application. The DSMP Template and Guidelines (MS Word, 85K) and DSMP Checklist (MS Word, 43K) were developed to assist investigators in preparation of a sound data and safety monitoring plan.
- The Sample DSMB Charter (MS Word, 53K) describes the responsibilities of the Data and Safety Monitoring Board (DSMB) to ensure ongoing, independent study review and assure the study is conducted according to the highest scientific and ethical standards.
- Guideline for Budgeting for Data and Safety Monitoring Activities (MS Word, 25K) aids investigators in budgeting for an independent DSMB or a Safety Officer when preparing the budget section of a grant application.
- Conflict of Interest for the DSMB Members - All members of the DSMB are required to be independent of the studies being reviewed and need to certify this by signing a DSMB Conflict of Interest and Confidentiality statement (MS Word, 30K).
- DSMB Reports Templates are provided as a guide to facilitate the development of comprehensive reports for submission to the DSMB. The DSMB usually approves the final content and format of the reports.
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:
- Informed Consent Template (MS Word, 108K) provides a general outline of a study specific informed consent document. It is crucial that investigators consult with their local IRB for any institution-specific templates and / or requirements regarding the format and content of the consent document.
- Informed Consent Checklist (MS Word, 55K) presents required and additional elements of the consent forms as set forth in Code of Federal Regulations.
Data Management Tips (MS Word, 42K) 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.
Study Forms can be customized for almost any clinical research study and include the commonly used demographics, study completion and other general forms including:
Glossary of Clinical Research Terms (MS Word, 64K) helps to define certain terms related to NIH funding of clinical research.
Page last updated Jul 11, 2008