2016 | 2017 | 2018 | 2019 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | |
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 |