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Standard operating procedures (SOPs) detail how a study will be conducted and who from the study 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.

The principal investigator or designee must formally train all members of their team on the specifics of the SOPs and document that this training has occurred on a Study Staff Training Log. Documentation ensures that you can demonstrate that the study has been performed per protocol.

Best practices call for a study team meeting at the beginning of each project to review study protocol, 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.

It is vital that you work to ensure 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 sessions and keep minutes to record that these events occurred.

Throughout the course of your study, and as study procedures and individual duties change, it is important to remember that investigators are responsible for making sure all members of their team are properly qualified, trained and supervised to do their jobs.

Learn More

The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.

Courses

ONLINE:

Good Clinical Practice and Study Management Basics (DCR)

Introduction to Clinical Research at Mass General (DCR)

LIVE TRAINING:

Clinical Research Spotlight Series: Communicating within Study Teams (DCR)

Clinical Research Spotlight Series: Delegation of Responsibilities in a Clinical Research Study (DCR)

Operationalizing Clinical Research Protocols (DCR)

Research Misconduct (DCR)

Leadership Strategies for the Researcher (Harvard Catalyst) 

Additional Support

See a list of the DCR’s current offerings

Many of the DCR's courses are recorded. Access our list of recordings and handouts

 

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