Why was his name on the return IP shipment and not in the site delegation log if he was involved in the study.

Initial Instructions: For this discussion board, I am asking you to put yourself in the position of a CRA manager who is tasked with closing out a clinical trial that includes a comparator that is a Schedule II compound, oxycontin to be exact.

 You receive a call from an investigative site to inform you that one of your contractor CRAs boxed up IMP for return several weeks ago, and they have yet to receive confirmation of receipt of the medication by the company.

 To make matters worse the drug return forms accompanying the shipment were not signed by site staff but by a friend of the contractor who is a pharmacist.

True Story.

Outline 3 total actions that should be taken by either the line manager, the sponsor, the site manager or the vendor who manages the contractor to address the situation.

 Please include 1 possible action to be taken against the contractor, and describe 1 potential audit, for example FDA, DEA that may be prompted by this incident.

Instructions for Assignment: Respond to the 2 following posts:

Atef

The responsibility of a site manager is to report any incidents or deviations to the CRA or sponsor company. 

The return shipment was signed by a non delegated staff, which is a breach of the regulations and 1572 agreement with the PI (NIH, 2021). 

The site should have conducted all procedures according to GCP and ICH guidelines.

 The other issue here is the drug is a scheduled II compound and should be investigated if there has been tampering with the IP packaging (Kleppinger, 2013).

As a site manager, we will fully investigate our clinical site and review the incident with our staff, we would write a CAPA and submit it to the sponsor and the FDA if needed.

The contractor company and staff will be investigated, and review his involvement in this trial. 

Why was his name on the return IP shipment and not in the site delegation log if he was involved in the study.

 If he is not involved or did not follow regulations correctly, a copy of the CAPA and incident would be sent to the DEA to follow up with the pharmacist, dealing with scheduled II drugs might also land the pharmacist under investigation with the office of criminal investigation (OCI) which could initiate a NIDPOE which is a notice of initiation of disqualification proceedings and opportunity to explain (Kleppinger, 2013).

The coordinator involved in this trial would be investigated about the incident, Why he did not sign on the return shipment. In this case, the FDA 483 would be necessary to review if a warning letter to the site should be submitted or not(Lehmann, 2019).

The clinical investigator also plays an important role in monitoring the quality of the studies as it is his main responsibility to assure his clinical trial is being conducted under GCP guidelines (NIH, 2021).

References

Kleppinger, C. (2013). Investigator Responsibilities – Regulation and Clinical Trials FDA’S 2013 Clinical Investigator Training Course.

Lehmann, J. (2019). FDA Form 483 And Warning Letters: What’s the Difference? Imarcresearch.com. 

NIH. (2021, June 30). Delegation of Duties Frequently Asked Questions. Nih.gov. 

Kia

In order to address this unique situation, the following actions will need to take place:

• The sponsor will request a root cause analysis (RCA) to be completed by the site manager, contract CRA, and CRA line manager so that the initial cause of the problem can be identified. 
• RCA is a problem-solving tool that is commonly used to identify the root cause of the problem rather than the apparent symptoms. 
• The “5 Whys” method supports the RCA by starting with the problem and then asking “why” at least 5 times until the source of the problem is identified (Pfieffer & Wells, 2017).
• Once the RCA has been completed, the sponsor will request a Corrective Action/Preventative Action (CAPA) plan. A CAPA Plan not only identifies and resolves the problem, but also pursues preventative action so that the problem does not recur. This plan is developed in memo format and typically includes the following information: date, problem, root cause, corrective actions, responsible personnel, timeline, date of resolution, preventative actions, follow-up plans, and additional comments (Pfieffer & Wells, 2017).
• The sponsor should request that the contract CRA be removed immediately from the study. 
• The contract CRA has violated good clinical practice (GCP) guidelines and did not follow appropriate monitoring procedure (according to the site monitoring plan) by having an external pharmacist sign off on the drug return forms instead of the site pharmacist. 
• The CRA line manager and contract vendor should terminate the contract CRA’s employment, as this type of unethical behavior is not acceptable in the pharmaceutical industry. 
• Additional penalties should be enforced after further investigation, such as the involvement of law enforcement. 
• OxyContin is classified as a schedule II controlled substance because of its high potential for abuse and high risk of addiction. 
• Simple possession charges can range from low-level felony to a misdemeanor, while possession with intent to distribute can lead to a life sentence in prison and a million dollar fine.
•  Enhanced penalties are added for distribution to minors or near schools (Pirius, n.d.).
• The site manager will complete a DEA Form 106 to report theft or loss of controlled substances. 
• Additionally, the sponsor can choose to submit a tip to the Drug Enforcement Administration (DEA) by completing the Rx Abuse Online Reporting: Report Incident Form. 
• This form reports illegal sales/distribution of prescription drugs such as, oxycodone and hydrocodone (Drug Enforcement Administration, n.d.). 
• This reporting could lead to an unannounced site DEA audit/inspection, where DEA Diversion Investigators will confirm if the controlled substance licensee is compliant with the Controlled Substance Act. 
• During the inspection, the DEA Diversion Investigators will analyze controlled substance licenses, authorized personnel logs, drug inventory logs, disposal records, storage of controlled substances, purchasing records, and theft/loss reports (University of Michigan, 2018).

References:

Drug Enforcement Administration. (n.d.). Submit a Tip for DEA. Diversion Control Division. Retrieved November 07, 2021, from

Pfeiffer, J. & Wells, C. (2017). A Practical Guide to Managing Clinical Trials. CRC Press.

Pirius, R. (n.d.). Sale and Possession of Oxycodone (OxyContin). Criminal Defense Lawyer. Retrieved November 15, 2021, from 

University of Michigan. (2018, January 10). Controlled Substance Compliance: DEA Inspection. Retrieved November 07, 2021, from