RAPID STUDY START-UP

Based on our experience in crisis-response settings, we’ve developed a key set of activities and resources that enable us to meet compressed trial start-up timelines.

We follow a core set of steps to achieve rapid study start-up:
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Initiate
Initiate pre-award operations with staff from multiple departments.
Clarify
Clarify roles and responsibilities of all personnel
Prioritize
Prioritize critical start-up activities and the corresponding staff
Deploy
Deploy technical teammates and hire in-country staff
Conduct
Conduct in-country launch meeting with key staff
Rapid Project Launch (RPL)

We’ve developed key resources, an expanded project team and a process to review all aspects of starting a new study. 

Resources

  • Checklists of key activities to be completed
  • Lists of organizational resources to assist with registering an in-country NGO, establishing a bank account, initiating payroll processes, procuring supplies and promptly paying vendors

Project team

  • Clinical project managers
  • Contracts and grants specialists
  • Finance managers
  • Human resources representatives
  • Procurement personnel
  • Senior management

Daily meeting

  • Prioritize tasks
  • Anticipate potential problems
  • Take action to overcome any barriers
Meeting compressed trial start-up schedules

 In the Sierra Leone trial to introduce a vaccine against Ebola (STRIVE), the study team succeeded in reaching first patient, first visit (FP/FV) six weeks after arrival in Sierra Leone. 

February 23
Deployed first members of the project team to Sierra Leone 10 days after the letter of authorization; hired and trained local project management and data entry staff
February 23
Early March
Deployed the first CRAs to Sierra Leone
Early March
March 18
Hired 28 local staff
March 18
March 23
Provided GCP and study-specific training to more than 300 newly hired study staff
March 23
Early April
Team established cold chain and began supporting trial vaccination sites as they opened
Early April
April 9
Opened first vaccination site in the Western Rural district and enrolled the trial’s first patient, just over six weeks after the start-up team arrived in Sierra Leone
April 9
May - June
Opened three more vaccination sites: two in May and one in June
May - June