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Monitor Responsibilities: A checklist review by types of visits to the site

Pre-Study
1. Monitor should maintain training records for protocol and drug accountability for each study 2. Monitor to maintain documentation and updates from sponsor on drug accountability issues (expiration updates, extension updates, requirements for shipping back, vender contact, IP release information to sites) 3. Confirm that the investigator has received a copy of the Investigators Brochure and its contents have been discussed 4. Determine who is delegated to handle IP. Confirm that if a pharmacy is being utilized, that the process is properly documented in the delegation log. Confirm that the pharmacy operating procedures will co-inside with study and site procedures for IP (ex. Pharmacy closed on weekends - will PI be able to access drug if needed on weekends? Where will drug be shipped? Is the 1572 properly documented with pharmacy information?) 5. Provide sites with written instructions and reference material and necessary forms for receipt, storage, handling, dispensing, accountability and return of IP a. Accountability forms (master log, subject specific dispensing/returning log, drug discrepancy forms, drug destruction forms, if applicable) b. Instructions for confirming receipt of drug/device (ex. IVRS being used, provide instructions for setting up accounts and confirm site can access IVRS or has been confirming receipts) c. Confirm site-specific forms meet minimum standards if site requires to use their own forms. Confirm approval with sponsor and document this approval in report 6. Confirm randomization envelopes for unblinding are filed or confirm site has access and training for unblinding procedures. Receive signature from PI confirming his understanding of IP unblinding procedures 7. Check all storage conditions including temperature, humidity, measures against rodents, general storage conditions (back up generator, windows/door area) - ensure areas (ambient closet, refrigerator, freezer) are properly monitored and appropriately documented for calibration and temperature with site staff initials or signature of recorder. Optional: review site SOP on this step and request a copy (most sites have one) 8. Confirm that there is enough space at the site to handle the amount of drug the site is contracted to handle (ex. Subject load) and can handle additional drug if required due to expiration of previous drug or recall. (ex. Quarantine procedures and storage) 9. Confirm and talk with site staff who are delegated by PI to handle IP

Study Initiation:
When initiating the study, it is important to confirm:

That the drug has arrived PI understandings the preparation needed for the drug Does the PI understand the requirements for drug accountability and requirements for drug compliance (along with any requirements per protocol) Is PI aware of how to confirm drug receipt with sponsor system (ex. IVRS)

On-Site Monitoring During Study


1. Confirm that the site is receiving appropriate amount of drug (not too much, according to the study set procedure, not too little). Check that the storage continued to be limitedaccess, secured, adequate, and locked 2. Confirm that the site is calling in / confirming receipt of drug and documenting this in the desired format. The person confirming shipment MUST sign and date. Confirm these dates are within the appropriate amount of time. Discuss with site if this step is not being done. 3. Confirm that there is no temperature excursion or damage to any packages. 4. Review dispensing procedures and documentation with pharmacy throughout study to confirm consistency with process and with documentation in the regulatory file 5. Count returned IP by subject, verify dispensing of IP against source documentation, and subject specific IP log, pharmacy documentation, medical records (if appropriate) and complete all required sponsor forms. If none, document on report, status. 6. Check CRF entries and other records related to IP used or returned by subjects against the returned material on-site and document any discrepancies, review discrepancies with site staff and obtain documentation resolution /explanation of any discrepancies 7. Obtain copies of IP documentation filed by the site from the Regulatory file when reviewing regulatory (every 3 months or as needed per monitoring plan) for monitor's file. Be sure that all received drug to site has a corresponding receipt in the regulatory file 8. Confirm expiration date for drugs or combination products. 9. Confirm that all quarantined drug or malfunctioning devices are properly documented and shipped back 10. Check storage conditions of the IP, documentation of the storage conditions, filing of documentation for storage conditions 11. Confirm that site continues to document in the source, drug return, calculation of compliance, compliance being within the protocol, actual days used within the calculation, reconciling of subject if needed, sponsor notifications are filed with approvals if subject was noncompliant. Discuss with site if this documentation is not clear and obvious for ANY issue that is not 100% compliance. Any issues must have documentation with a reason and resolution. 12. Any outstanding issue should be clearly discussed with the site, documented in the report and in the follow up letter with a resolution date in the follow up letter. o Severe noncompliance, multiple issues - discuss with PI.

Its important that the site is ensuring that IP is accounted for and discussing this with the subject ongoingly. o Reassurance of issues with a single subject is unacceptable especially without a reason and preventative plan documented in the source. A monitor must bring all issues to a site's attention from the very start of the study and before there is a serious noncompliance or multiple violations. o Each nonreturn of a drug and each failed compliance is a protocol deviation and must be documented in the sponsor's specified Deviation log. This, therefore, must be discussed it that PI and documented in the follow up letter. o Multiple issues with one site is also unacceptable. Be sure that that site understands IP requirements and retrain as needed. If retaining is done, be sure to discuss with PI and document in the report. Monitors must document issues and addressing them proactively. o IP is highly regulated and every effort must be made to get the drug back. Subjects who state that the drug was lost should be approached with a plan to have the drug returned. o Subjects who call site to discontinue from the study should be sent a certified letter with return envelop for the swift return of the drug. o Subjects and sites that do not comply with this or have multiple violations must be handled swiftly to help prevent further action. 13. Ensure that what the subject is reporting makes sense.

Close the site

Perform a final reconciliation of IP and confirm that accountability and drug status is documented in the regulatory for the entire study for all subjects and 100% accounted for. This will include a copy of each subjects running IP log of all dispensed drug by number, date, staff and its return date with any comments (ex. Missed half dose on Tuesday, June 15th), master drug log, receipts of drug received and confirmed at the site from the vender, all destroyed drug. Retain copy of this documentation and send copy in to central filing. Document and resolve any discrepancy per sponsor operating procedure. Confirm that no subjects were unblinded or confirm that any subject that was unblinded is properly documented and sponsor approved the unblinding before it occurred with proper documentation on site. If 100% drug accountability: If shipping back to sponsor 1. Package all drug (used and unused) 2. Have site confirm all package numbers against all IP log information to confirm 100% accountability 3. Have site sign drug accountability form to confirm agreement

4. Secure the package with tamper proof tape and sponsor / vender supplied shipping label. Confirm pick up with study coordinator and shipping method. 5. Fax shipping form to vender to confirm that they are notified of the package that is on its way 6. Confirm its arrival back to the vender by tracking package) 7. Retain copies of all IP in case of questions, audit, discrepancies 8. If destroying at site: 9. Confirm accountability of all drug 10. Confirm all documentation is filed, signed, and copies sent to sponsor and monitor 11. Confirm that the sponsor's approval of the site's ability to destroy drug 12. Confirm site's SOP for destroying drug 13. Depending on the study, the monitor does not have to be present during the destruction process as long as the above steps are done

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