In the race for a vaccine, Russia recently unveiled “Operation Sputnik,” approving a vaccine ready for human use and is being administered to essential workers. Russia is the first country to claim it has a working vaccine. China revealed it has approved an experimental vaccine and is administering doses to high-risk professionals and military personnel. The United States announced “Operation Warp Speed,” spending billions on pharmaceutical contracts to manufacture and distribute a COVID-19 vaccine. Several pharmaceutical companies around the world are in the final phases of the vaccine clinical trials.
From preclinical testing to the last phase of clinical studies, it takes years for an experimental drug to be manufactured and produced for human use. The COVID-19 vaccine has been fast-tracked to be manufactured and ready for human use within a matter of months, not years. The expedited development brings up concerns about managing the amount of data gathered for these trials and the speed at which the procedures and documentation are occurring. To demonstrate compliance with Good Clinical Practice standards, every essential aspect of a clinical study must be documented.
The United States Food and Drug Administration produced a guideline in March 2020 (updated in July 2020) outlining procedures for clinical trials during the pandemic. The document refers to Part 312 of section 21 of the Code of Federal Regulations which addresses the records that need to be kept for new pharmaceutical drugs, including regulations for clinical investigators. The 2020 guidance document highlights procedures for obtaining and keeping consent documentation. “When feasible, we recommend a traditional method of obtaining and documenting informed consent using a signed paper copy of the consent form, or use of electronic informed consent”. But what if the written consent by the trial participant is not possible? The USDA guidance document provides two additional methods for consent:
- “Method 1: A photograph of the signed informed consent document can be transmitted to the trial staff. The patient (or an individual in the room) takes a photograph of the signed informed consent document and sends it to the investigator/designee. A trial team member enters the photograph into the trial records along with an attestation that states how that photograph was obtained and that it is a photograph of the informed consent document signed by the patient.”
- “Method 2: A witness can attest to the signature, but a photograph of the signed informed consent document cannot be transmitted. When using a witness, documentation in the trial records includes: (1) a signed and dated attestation by the witness who participated on the call that the patient confirmed their agreement to participate in the trial and signed the informed consent document.
The European Medicines Agency also produced guidance documentation regarding Clinical Trials and procedures. This document also refers to Directive 2001/20 EC Good Clinical Practice for the conduct of clinical trials on medicinal products for human use which addresses record-keeping practices. The guidance document added:
…the following specific aspects should be taken into account with trials involving COVID-19 patients:
- If written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent could be given orally by the trial participant (Art 2(j) of Directive 2001/20/EC) in the presence of an impartial witness. In such cases, the witness is required to sign and date the informed consent form and the investigator is expected to record how the impartial witness was selected.
- In addition, it could be considered that the trial participant and the person obtaining consent sign and date separate informed consent forms. In either case, all relevant records should be archived in the investigator’s site master file. A correctly signed and dated informed consent form should be obtained from the trial participant later, as soon as possible.
What about the pharmacovigilance aspect? Monitoring the safety of medicines is a top priority for pharmaceutical companies. The UK Medicines and Health Regulatory Authority released guidance as to what documents need to be kept for pharmacovigilance inspections since the manner of inspections have changed because of the pandemic. These documents include: “procedural documents (such as SOPs, working instructions, and guides); outputs from pharmacovigilance activities such as safety review meeting minutes; documented product safety reviews; audit risk assessments; agreements in place with partners and service providers”. The 2020 Guide by the USDA touches on pharmacovigilance data they require pharmaceutical companies to keep, “data, which includes the pre-licensure clinical safety database, preclinical data, and available safety information for related vaccines, among other considerations”. There will be extra scrutiny for pharmacovigilance documents as these vaccines are being used globally on a wider scale.
Good Clinical Practice has always set forth very particular and detailed standards for recordkeeping during clinical studies and trials. It is now more important than ever to adapt to regulatory changes. Pharmaceutical companies are receiving, reporting, and creating records on the effectiveness of the vaccine at an accelerated rate. Contact Zasio today to determine whether your company is up to date with the influx of clinical record keeping requirements, pharmacovigilance record keeping, and GDPR requirements.
Author: Heather Houle, CRA
Senior Research Analyst / Certified Paralegal