Assessing Feasibility
Section 2
Developing the Trial Documentation
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. 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
| 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 (e.g., data dictionary, data quality assessment, data harmonization across sites) | |
| 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 | |
| Informing participants; consent process and documentation | |
| Oversight | |
| Data and safety monitoring plan/committee | |
| Data management plan | |
| Quality management plan | |
SECTIONS
sections
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Interest Holders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources
Resources
NIH provides toolkits, checklists, and sample documents to assist study teams with planning; for example, National Institute of Dental and Craniofacial Research.
The Health Care Systems Research Network (HCSRN) has materials focused on planning and fielding research.
The Research Toolkit contains information and links related to all phases of research, especially starting a study.
current section : Developing the Trial Documentation
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Interest Holders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources