Table 1 Pragmatic trial planning: general framework for milestones and metrics

 Develop and document collaborations and partnerships

1. Copies of Memo of Understanding or contracts with organizations involved in the clinical trial

2. Copies of signed agreements of clinical sites (if applicable)

3. Copies of letters of support from study champions/investigators in relevant delivery locations

4. Copies of executed data use agreements

 Finalize protocol, manual(s) of procedures, data collection forms

1. Copy of Institutional Review Board (IRB)-approved protocol

2. Copy of final manual of procedures

3. Copies of IRB-approved data collection forms (if applicable), including methods for data management and data quality

4. Validated methods to collect data from existing electronic sources (if applicable)

5. Demonstration of methods for integration of data collection forms into electronic resources (if applicable)

 Achieve necessary human subject protection approvals and procedures

1. Copy of IRB approval to conduct clinical trial

2. Copy of IRB-approved informed consent (if applicable)

3. List of Data and Safety Monitoring Board (DSMB) members and copy of DSMB charter

4. Final IRB-approved data and safety monitoring plan

 Evidence of adequate potential study population

1. Environmental survey of potential study participants (with estimates by site and plan for tracking progress)

2. Recruitment plan with recruitment milestones, alternative strategies, and participant invitation (if applicable)

 Patient information management

1. Evidence of feasibility of data collection materials, sources, and processes

2. Documentation of methods for adding patient follow-up information to the trial database

 Equipment, staff, training, and budget

1. Documentation of equipment requisitions, availability of adequate and appropriate staff, and budget in line with trial needs

2. Documentation of training needs and training curriculum