The Conduct of a Clinical Investigation or the Supervision Failure Noted By the FDA During Auditing

The letter is in response to a warning letter on 30th April 2014. The basis of the warning message letter focused on the conduct of a clinical investigation or the supervision failure noted by the FDA during auditing. About failure of personally conduct or supervision of the clinical investigations (21 CFR312.60), I acknowledge that I am eventually responsible for the conduct of clinical investigations and specifically for the supervising the investigation. I am establishing correction on that part issuing a procedure for having the problem fixed. I have ensured that all the staffs are adequately trained, and I am maintaining the recording of the data being collected during investigations on August, and the training is still ongoing.

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I have also taken my responsibility in seeing to it that the training staff does not handle the supervision alone. I acknowledge the fact that I had promised to rectify the problem, but I failed to do so. I have at this moment established a safeguarded place so as to minimize the familiar risks that reoccurred. The safeguards include having a team meeting before new routine and protocols. Orientation and educational training for the research staff are also in motion. The issue concerning the response made on June 3, 2013, to the form FDA 483, I had promised to retrain the staff but was caught up by time.

I failed in improving delegation and supervision procedures whereby the corrective action plan was insufficient. I at this moment plan to improve the safeguarding policies so that the past failures cannot be repeated. I have, and I am continuing to improve the informed consent process, and I have come up with a written tool that will ensure documentation since I would not want the problem to repeat in the subsequent inspections in the future.

My former research nurse worked under my supervision from September 15th, 2013 until July 11th, 2014. There are some signatures from parents as well as initials that I noted they were forged by my former nurse I presumed. I discovered the issue of falsified signature five months later through an internal audit that I had requested. I noted my research nurse had other signatures falsified too on several forms that had misplaced. I confirmed to my disappointment that she was not clean since apart from me, she was the only person authorized to access the documents.

I understand my responsibility in ensuring that the staff is adequately trained and supervised. To make sure this does not happen again, I put a team in charge of new protocols. The team would ensure that the reviews are done on allocation of tasks, drug dosing, study procedures, research documents and expectation for study data documentations. In the case of inquiry, representatives can be consulted, and they can give a guideline on how the process can be made. Since the audit, I have carried out two meetings in which I was the PI. Some educations sessions have been launched and carried on in which I encouraged my staff to attend and saw to it that topics like institutional policies and good clinical practice are covered. The training that I have introduced to the team is documented, and certificates of attendance and achievement of training offered to every staff involved. The documents are attached to the personal files of the attendees.

I am responsible for the incorrect records and in the future I will make sure that I will supervise the staffs that are delegated to transcribe and calculate doses are adequately trained. The error made of wrong diagnoses and dosage should have been noted since three staffs usually do inspections. If the three sponsors had noted the data carefully, then the error could have been known in time. I have therefore decided to unlock the database to review the durations calculations as it would not affect the dose administration to the individual and subjects.

I have improved the new way of avoiding future errors keeping in mind that I had made similar promises, and then I experienced some failures in the correction plan. I have therefore generated a computer train-of four watches which can be able to infuse dosage at the correct time and to the right person. I take responsibility for ensuring adequate supervision and the oversight of the activities carried out by my staff. I have briefed my staff on the importance of appropriate documentation, and the consent process and together have put out a policy for my staff whereby if a person needs to obtain approval to complete additional study, the occurrence and the detail of the informed process should be well programmed and established.

I regret the existence of the concerns that have been reported to me and identified by the FDA and also the circumstances that led to the incident. I have successfully worked with other colleagues, and such incidents have not been happening for many years. Out of this concern and to stop future failures, I have taken steps that will see to it that the risk of certain happenings will not occur.

Considering the warning on the inability to prevent theft or diversion of an investigational drug that is subject to the Controlled Substances Act (21 CFR 312.69), I take the responsibility that the operating procedures about pharmacy were not reported. Also, a copy was also not provided indicating whether the corrective policy was initiated and if it is still working. I had made sure that all the staffs were aware not to divert the drugs and after I did my supervision I noted that two of the staffs had conspired to divert the drug illegally.

I acknowledge the mistake was mine since I did not take keen when the staffs were under supervision by the team, and since they had access to the drug storage, I presumed they were the culprits. Three months later, I confirmed that the security was breached, and the two securities were taken care of and made sure that an example was set. I was able to form a team that ensured that phone conversation was followed up by every employee so that no attempt should be made. Extra CCTV cameras were placed, and reviews are being sent in due time. I have implemented new surveillance, locked that are automatic and can be opened only by me and authorized to open by fingerprints, only chosen and certified individuals will have access and after some time they would be relocated, and security details changed so as to be cautious. I have sent a review to the FDA to certify the corrective plan so as to be adequate.

In summary, I regret the miscommunication and the concern that have been raised in the institution, and I am willing to provide any information that the FDA might need clarity. I have taken the above steps to minimize the risk that the FDA had noted and prevent it from reoccurring. Please do not hesitate should you need to contact me with any further concerns or clarity. Thank you

Sincerely

Ana J. Fandino, M.D.

10281 SW 72nd Street

Suite 101

Miami, FL 33173