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University of Minnesota's CT monitoring plan
Check out these sample check-off items
The University of Minnesota in Minneapolis, MN, has a 10-page clinical trial monitoring plan used by in-house monitors to ensure clinical trials initiated by investigator sponsors are following good clinical practice (GCP) standards.
Here are a few sample items from the monitoring plan:
• Item 3.4: Verify the site follows the approved protocol. To accomplish this, the monitor will:
- Verify the (current) IRB approved protocol and the (current) protocol in the master file are the same.
- Compare data to be collected on case report forms (CRFs) with the IRB approved protocol (data collection should not exceed the limits defined by the protocol).
- Verify the number and type of subjects entered into the study was confined to the number and type of protocol-defined eligible.
- Verify that no deviations from or changes to the protocol have been implemented without prior review and documented approval of the IRB (except where necessary to eliminate an immediate hazard to trial subjects or when the change involves only logistical or administrative aspects of the trial).
- Verify the labels on the individual patient bottles/medical devices comply with the requirements for investigational drug or device labeling.
• Item 3.5: Ensure trial staff is adequately informed about the trial and has not delegated responsibilities to unauthorized individuals. To verify this, the monitor will:
- Note the identity of all persons and locations obtaining raw data or involved in the collection of data by looking at authorization log kept at site (FDA Compliance Program Guidelines, Part III). (If there is no site authorization log, the monitors will require that one bye completed and updated throughout the trial).
- Check documentation for information about distribution of the currently approved protocol and investigator brochure to the study team.
- Check documentation of any protocol specific training of authorized individuals.
- Compare study documents, the IRB application, and the site authorization log to determine whether responsibilities have been delegated to unauthorized individuals.
• Item 3.9: Verify trial records are accurate, complete, and current. To accomplish this, the monitor will:
- Verify the investigator or assigned designee has completed current CRFs -- and that they are signed and dated appropriately.
- Verify source documentation was used to complete CRFs.
- Verify the protocol identifies source data that will be recorded directly on CRFs (with no prior written or electronic record of data).
- Verify whether clinical laboratory testing (including EKGs, X-rays, eye exams, etc.), as noted in the case report forms, is documented by the presence of completed records among the source documents. (FDA Compliance Program Guidelines, Part III).
- Verify the site's data and source documents in terms of their organization, condition, completeness, and legibility. (FDA Compliance Program Guidelines, Part III).
- Verify the investigator has made required reports and submissions to the regulatory authorities.
- Verify the information in the reports to information in the study master file and source documents to verify accuracy and completeness, including reports of any adverse experiences.
• Item 3.13: Determine all essential documents are maintained. To verify this, the monitor will:
- Verify that all applicable documents exist and are current as of date of monitoring. The following documents are essential documents:
- Transfer of Monitoring Obligation Agreement
- IRB, FDA, and other regulatory documents (e.g., reports, correspondence)
- Signed protocol
- Investigator brochure
- Consent form and IRB-approved information for subjects
- Randomization procedure
- Sample CRF or document stating medical record is data collection form
- Investigator and sub-investigators CV or documentation of qualifications and training
- Site signature sheet
- Lab normal ranges
- Lab certifications
- Screening log
- Enrollment log
- Adverse event log
- Subject code list
- Product accountability log (IDS or registry)
- Product handling and storage instructions
- Product shipping records and certificates of analysis
- Record of retained samples
- Decoding procedures for blinded trials
- Record retention plan
- Monitoring reports.