|
Protocol development
|
X
| | | | | | | | | | | | | | |
|
Training of research coordinators and physicians
|
X
| |
X
|
X
| | | |
X
| | | | | | | |
|
Training of nurses for motivational counseling (yearly refresher training)
| |
X
| | |
X
| | | |
X
| | | | | | |
|
Obtaining informed consent, recruitment, and baseline interview
| | | |
X
|
X
|
X
|
X
| | | | | | | | |
|
Auditing and site visit monitoring (every 2 weeks)
| | | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Trial supervision
| | |
X
| | | |
X
| | | |
X
| | | |
X
|
|
Monthly Trial Management Committee meeting
| | | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Telephone follow-up by nurses (monthly until 3 months and then every 3 months)
| | | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Follow-up by clinical research coordinators (every 4 months by telephone; annually on site)
| | | | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Data Safety and Monitoring Board meeting (every 6 months)
| |
X
| | |
X
| |
X
| |
X
| |
X
| |
X
| |
X
|
|
Trial Steering Committee Meeting (every 6 months)
| |
X
| |
X
| |
X
| |
X
| |
X
| |
X
| |
X
| |
|
Quality assessment
| | |
X
| | |
X
| | |
X
| | |
X
| | |
X
|
|
Progress or interim report
| | | | | |
X
| | | | | | | | | |
|
Data analysis
| | | | | | | | | | | | | |
X
|
X
|
|
Manuscript writing
| | | | | | | | | | | | | |
X
|
X
|
|
Final report
| | | | | | | | | | | | | |
X
|
X
|
