MCEFT clinical trial committee
| Committee | Functions | |
| Study coordinator | Prepare case report forms Monitor fidelity Document and maintain study data Organise committee meetings Audit the trial and seek amendments to trial conduction Submit annual report and adverse event report to institutional review board | (Fidelity of intervention will be monitored using modified checklist. (Refer section Fidelity monitoring)) |
| Outcome assessor | Measure outcome Summarise data Verify for dropouts Submit outcome measure data to trial statistician | |
| Principal investigator (study therapist) | Design the protocol Recruit participants Revision of the protocol Conduct the study Collect study data other than outcome measures Prepare data for dissemination | |
| Study steering committee (three therapists with PhD degree with experience in conducting clinical trial) | Verify patient comfort in the study process Monthly verification of study progress Provide guidance and suggestions on study progress | |
| Institutional review board | Verify informed consent Verify amendments to protocol and approve changes in consultation with data management committee Monitor collected data Advice on adverse events | |
| Data management committee | Determine sample size Prepare statistical analysis plan Data verification Analyse the data |
MCEFT, multifactorial context-enhancing functional therapy.