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The standard operating procedures (SOP) for your study should delineate data-based duties—such as data entry and query resolution timelines—and designate who on your team will be responsible for these tasks. Make sure to include these duties in your Delegation of Responsibilities Log.

Remember the difference between source documents (wherever participant information is first recorded) and case report forms (CRFs – the forms where study data is reported) and utilize these data sources appropriately.

If you are not supplied with CRFs by your study sponsor, it is important that you work with your team to design CRFs that will capture the data required for your study.

Working with paper or electronic CRFs (eCRFs) can require different procedures. Make sure that you are clear how your study is going to be collecting data before you begin, and follow all procedures per protocol.

To ensure appropriate data collection and oversight, follow Good Clinical Practice Guidelines (download PDF).

All clinical research data should be entered into a database in a timely manner and should be checked for quality assurance (QA) on a regular basis. See the Partners QI Program’s Monitoring Plan template for guidance.

Make sure that someone on your team is responsible for performing QA procedures for your study, and that these procedures are detailed in your study’s standard operating procedures (SOPs).

Study databases that contain participant identifiers must be maintained behind the Partners Healthcare firewall and should be saved to a study-specific shared drive that is backed-up to an external hard drive on a regular basis. Be aware that you are required to follow Partners encryption rules on all computers and drives being used for your project.

Besides helping to manage data appropriately, the data entry and QA process can to help you monitor unanticipated problems and adverse events (AEs) within your project. The Adverse Events Tracking Log is the tool to use to document AEs for your project.

 

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.

Resources

Courses

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Additional Support

 

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