Developing the Trial Documentation

Assessing Feasibility

Section 2

Developing the Trial Documentation

Contributors

Lynn L. DeBar, PhD, MPH

Jeffrey G. Jarvik, MD, MPH

Leah Tuzzio, MPH

Miguel A. Vazquez, MD

 

Contributing Editor

Liz Wing, MA

The checklist below suggests documents needed for fulfilling regulatory requirements as well as other comprehensive records of the trial’s conduct. Note that the required or recommended documents will vary depending on the particulars of the intervention and related contractual agreements, but it will be beneficial to be as thorough as possible at this feasibility phase. Also, teams should expect that these documents will undergo modifications, possibly multiple times, both before and during the trial.

Pilot testing informs the trial’s needs and how to plan for challenges with staffing, recruitment, data collection, intervention timing, and other elements. For example, in large healthcare systems, conditions may shift or new initiatives may be disseminated within the system and thus require flexibility in, for example, committee membership, modes of communication, staffing, or training. Such ongoing considerations are important for study teams involved in implementing embedded PCTs in real-world settings.

Documentation Checklist

Download as Word or PDF

Document Completed
Study-related
Protocol
Staffing plan, including multisite organization chart
Recruitment plan
Statistical analysis plan
Budget
Contractual documents (e.g., memorandum of understanding [MOU], reliance agreement)
Electronic health record use plan and IT-facilitated updates as needed  
Study plan and timeline  
Communication plan
Committee membership and meeting plan, including advisory and steering committees  
Manual of procedures
Data coordinating activities
Patient recruitment and intervention materials
Clinical staff training and intervention materials
Interviewer/research staff training
Vendor contracts
Specimen management plan
Site initiation plan
Dissemination and sustainability plan
Regulatory
Data sharing plan including data use agreements between parties
IRB review and approval
Registry in ClinicalTrials.gov
Informed consent process and form, if applicable
Oversight
Data and safety monitoring plan/committee
Data management plan
Quality management plan

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Citation:

DeBar LL, Jarvik JG, Tuzzio L, Vazquez MA. Assessing Feasibility: Developing the Trial Documentation. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/assessing-feasibility/developing-the-trial-documentation/. Updated September 14, 2017.