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Draft Standard Operating Procedure (SOPs) for your study

Information:

  • In clinical research, Standard Operating Procedures (SOPs) help define the standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidance.
  • SOPs should contain enough detail to guide research staff through a particular procedure and thereby establish uniformity in the everyday functions related to that study.
  • SOPs should contain specifically defined procedures that can be followed without deviation.
  • Common SOPs include:
      • GCP Training
      • Authority and Delegation of Responsibilities of Research Staff
      • Subject Screening and Recruitment
      • Informed Consent Process and Documentation
      • Eligibility Confirmation
      • Source Documentation
      • Data Management
      • Protocol Deviations
      • Adverse Events and Serious Adverse Events Reporting
      • Confidentiality of Information
      • Drug/Device Storage, Accountability and Management
      • Regulatory Document Submissions (Initial, Amendments, Continuing Reviews)
      • Sample Processing and Shipping Training
      • Monitoring Visits
      • Sponsor, CRO and Internal Audits
      • FDA Audits
      • Record Organization and Retention
      • Sub-Site Management

Resources:

MGH Clinical Research Program Project Manger SOPs
Partners QI Program Guidance for Clinical Research SOP Writing
Partners QI Program Investigational Product Accountability Sample SOP
Partners QI Program Obtaining Informed Consent Sample SOP
Partners QI Program Sample SOP Cover Page

Courses:

ONLINE:
Introduction to Clinical Research at MGH

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts.