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

Leverage our proven toolbox of resources for rapid study start-up.

Designed to support the entire study timeline, our resources have been developed and tested over our long history of conducting studies in challenging settings. These resources have been developed to aid with study start-up and conduct for sites with limited research experience.

Contracts
Templates and examples of contracts that span the typical study needs, including procuring supplies, consulting, laboratory services and more
Contracts
Standard operating procedures (SOPs)
Templates and examples of SOPs for studies of all types, including clinical trials, epidemiological studies and behavioral studies
Standard operating procedures (SOPs)
Checklists of key activities
Comprehensive lists of activities that should be completed during the study planning, start-up and conduct phases
Checklists of key activities
Plans
Templates and examples for monitoring, data management, statistical analysis, lab conduct and safety
Plans
Lists of organizational resources
Resources that assist with registering an in-country NGO, establishing a bank account, initiating payroll processes, procuring supplies and promptly paying vendors
Lists of organizational resources

contracts

Templates and examples of contracts that span the typical study needs, including procuring supplies, consulting, laboratory services and more
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

Project team

Daily meeting

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