Lead & manage study team
- Standard Operating Procedures (SOPs) detail how a study should be conducted and who from your team will be responsible for each activity from study initiation through closure. SOPs are a necessary planning and training tool for study team members and should be developed and updated throughout the course of your study.
- Formally train all members of your team and document that this training has occurred on a Study Staff Training Log. Remember – “if it isn’t documented, it didn’t happen.”
- Best practices call for a study team meeting at the beginning of each project to review study protocol and procedures and individual duties. Be sure to keep a sign-in sheet to document who attended these trainings.
- As delegation of duties occurs, specify these on a Delegation of Responsibilities Log and update this log regularly.
- Things change often in clinical research, so it is vital that you work to ensure that all members of your team are made aware of all changes and that they are clear about how these changes may impact their work. Establish regular meeting times, integrate continued training and keep minutes to record that these occurred.
- Throughout the course of your study and as study procedures and individual duties change remember: Investigators are responsible for making sure that all members of their team are properly qualified, trained and supervised to do their jobs.
▪ Clinical Research Program Clinical Research Coordinator Orientation Checklist
▪ How to Explain Non-Credentialed MD’s Roles to Research Subjects
▪ Human Subject Protection Education and Training Requirements for Investigators and Study Staff
▪ MGH Research Staff Certification (Doctors Not Credentialed to Practice at MGH)
▪ Principal Investigators and Delegation of Study-Related Tasks to Co-Investigators and Study Staff