Agency Forms for Clinical Drug Trials
How to use existing clinical trial forms to meet research requirements and maintain best practices
Agency forms for clinical drug trials assist investigators in meeting defined requirements and codes of conduct for clinical trial research. Specifically, forms for clinical trials aid investigators in maintaining best practice protocols.Using agency forms for clinical drug trials helps maintain consistency by reducing variability in protocols, terms and definitions.
Forms used in clinical trials can be obtained from:
- Government agencies such as the U.S. National Institutes of Health (NIH).
- Contract research organizations (CROs) and clinical research agencies, which offer services such as product and protocol development, clinical trial and data management, laboratory processing and marketing.
- Patient recruitment agencies, which specialize in recruiting patients for clinical drug trials, including pre-screening, enrollment and retention.
Review government agency forms for clinical drug trials to determine applicable regulations
The NIH is the lead federal agency supporting clinical research in the U.S. NIH's Clinical Research Policy Analysis & Coordination (CRpac) Program oversees clinical research compliance to promote the efficiency and efficacy of the industry.
The International Biopharmaceutical Association provides an international forum for the collaboration of biopharmaceutical and clinical research institutions.
Try: The NIH's Forms and Applications website provides downloadable forms for clinical trials, particularly to meet NIH-funded grant requirements. The CRpac provides specific policies and forms for clinical trials to report adverse events, design and monitor clinical trials, obtain informed consent as well as review human subject regulations. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) provides clinical drug trial forms related to drug safety and the drug approval application process. The International Biopharmaceutical Association publishes a monthly newsletter and provides access to a variety of pharmaceutical industry publications.
Review the clinical research forms that have already been compiled by information service companies
Information service companies perform the legwork for you by providing directories of clinical research organizations and related resources where you can view examples of forms for clinical trials or obtain the actual forms used in clinical trials.
Try: CenterWatch's Investigative Site Identification Services profiles research centers and identifies sites for investigators to conduct upcoming trials. The Center for Information and Study on Clinical Research Participation (CISCRP) works with the public and medical community to provide general information about clinical trial research. ClinicalStudyResults.org is a web-based repository that publishes clinical study results to increase transparency in pharmaceutical reporting.
Review sample clinical trial forms provided by CROs and patient recruitment agencies
Contract research organizations and patient recruitment agencies publish sample clinical trial forms that serve as excellent resources when customizing a form for clinical trial.
Try: Look at the Tools and Forms section of the Oregon Clinical and Translational Research Institute (OCTRI) for clinical research forms. Joslin Diabetes Center's protocols, published by its Committee on Human Studies, are geared to protect the rights of the humans used in clinical research. Other good sources to find clinical research forms include Clinical Connection, Clinical Trial Media and Criterium, Inc.
- Always make sure the forms used in clinical trials detail the human subjects' rights under the law.
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