The policy requires inclusion and subpopulation data in the progress report for each NIH-defined Phase III clinical trial grant or contract. Does that mean that analyses need to be done every year?
NO. The progress report needs to report cumulative accrual data annually and explain progress in conducting analyses for sex/gender and/or racial/ethnic differences. If analyses of sex/gender and/or racial/ethnic differences are not available at the time of the progress report, then a justification and/or interim data analyses must be reported. Analyses should be conducted when permitted by the study design and as described in the analysis plan. For contracts, the schedule of deliverables will dictate when reports and analyses are required.
Related Questions
- The district’s debt management policy requires the Board to prepare a quarterly derivative report. How is this requirement fulfilled?
- Can different subjects be added to the progress report, or a free form text field for data entry?
- Who requires a Progress Report? What happens if I do not submit a progress report form?
