Site identification and development
- Establish partnerships
- Upgrade facilities and laboratories
- Get protocol approved
- Conduct formative research
| Communications planning
- Develop your budget
- Conduct your environmental scan
- Identify your communications team
- Orient staff to communications procedures
| Chapter 2 |
Site initiation training
- Good Clinical Practices
- Ethics orientation
- Protocol requirements, etc
| Develop strategic communications plan (including crisis management and outline of results dissemination plan)
Choose spokespeople; conduct initial media training | Chapter 3 |
| Trial launch: enrollment begins | Trial launch
- Inform key stakeholders identified in your strategic plan
- Mention enrollment milestones in trial newsletter or updates to key stakeholders
| Chapter 4 |
| Interim data analysis | Data and Safety Monitoring Board (DSMB) meets
- Prepare scenario messaging for all possible review outcomes
- Inform research colleagues at closely related trials so they can be alert to possible ramifications of DSMB recommendations
- After reviews are conducted, communicate outcomes to stakeholders
| Chapter 4 |
| Data collection completed | Finalize results dissemination plan | Chapter 6 |
Release results
- Inform authorities
- Unblind participants
- Submit scientific papers
| Implement dissemination strategy
- Inform key stakeholders
- Work with the media
| Chapter 6 |