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eQMS для наук о жизни Пунктов: 19

GCP Clinical Site Monitoring Visit Checklist (ICH E6)

Этот чек-лист на английском языке.

Structures a clinical research associate's on-site monitoring visit to verify subject protection, data integrity, and protocol compliance at an investigational site. Use for interim monitoring visits.

ICH E6(R2)21 CFR 31221 CFR 5021 CFR 56

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Regulatory and Essential Documents

  • Is a current IRB/IEC approval on file for the protocol and current amendments? *
  • Are signed protocol, CVs, and financial disclosure forms current in the site file? *
  • Is the delegation of authority log current and consistent with actual activities? *
  • Is the current investigator's brochure available at the site? *

Informed Consent

  • Is a signed, dated informed consent on file for every enrolled subject prior to any study procedure? *
  • Was the correct IRB-approved consent version used for the date of signing? *
  • Were subjects re-consented for relevant amendments affecting their participation? *
  • Record the number of consent forms reviewed this visit.

Source Data Verification

  • Do CRF/eCRF entries reconcile with source documents for reviewed subjects? *
  • Are eligibility criteria verified against source for enrolled subjects? *
  • Are protocol deviations identified, documented, and reported per plan? *
  • Are data queries reviewed and resolution status assessed? *

Investigational Product Accountability

  • Is IP stored under the required conditions with monitored temperature? *
  • Does IP accountability (received, dispensed, returned, destroyed) reconcile? *
  • Is randomization/blinding maintained and unblinding controlled? *

Safety Reporting and Follow-up

  • Are adverse events and serious adverse events documented and reported within required timelines? *
  • Are SAEs reconciled between the site and the sponsor safety database? *
  • Are prior visit action items closed or tracked? *
  • Is a monitoring visit report and follow-up letter completed? *

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