Skip to main content

Clinical Development Resources

Browse our clinical development resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Initiation and Monitoring SOP Considerations

While you are developing SOPs on initiation and monitoring, you should keep these points in mind:

  • The Principal Investigator or his/her designee will schedule and arrange the initiation and monitoring visits as requested by the sponsor representative. Attendees will include all pertinent staff (if available). The visits or sometimes, remote communications, will occur at intervals defined by the sponsor and often will depend on the status of enrollment.
  • Monitoring visits will be scheduled at mutually convenient times and every attempt will be made to accommodate monitoring deadlines.
  • Correspondence regarding changes to schedule visits (whether it is coordinator or monitor initiated) will be documented in the investigator site file.
  • Prior to each visit, the Principal Investigator designee will confirm with the sponsor representative what materials will be reviewed so that appropriate documentation and files will be made readily available. These materials will include:
    • Subject source documents and corresponding case report forms (CRFs)
    • Investigator Site File
    • Safety reports and/or Adverse Event documentation
    • Access to study drug storage and accountability documentation
  • The assigned/authorized staff  will make sure that an appropriate work area is available for the monitoring visit. The work area will include:
    • Quiet location
    • Phone access
    • Internet access
    • Copy machine access
    • Desk and chair
    • Data ports for computers (if necessary)  
  • The Principal Investigator designee will schedule time to work with monitor during the visit to review and complete any data clarifications as necessary.