By Penelope Przekop, MSQA, RQAP-GCP
Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience to perform their assigned task(s). To start, job descriptions, CVs, and organizational charts are the three pieces of low-hanging fruit when it comes to demonstrating qualifications. Training documentation is the fourth component required to ensure that everyone involved understands the process and documentation required to maintain data integrity and patient safety.
We have solid industry standards around dovetailing the four components above to produce clear documentation that satisfies regulators. Although not always easy to implement, the components are straightforward when it comes to internal biopharma employees. However, the industry shift to decentralized clinical trials brought added complexity. Thankfully, companies are making progress on how to ensure that vendors’ staff are also qualified.
Then comes the independent consultant, also referred to as a part-time consultant, contracted to execute specific good clinical practice (GCP) tasks that are not needed or required on a consistent basis. Training requirements and processes for this group of GCP-focused individuals causes the most head scratching, debate, confusion, blank stares, and frankly, wasted time. Both operational and quality assurance (QA) professionals are challenged to balance compliance with common sense and risk when it comes to this scenario.
To avoid wasting valuable time having multiple circular discussions about this topic, consider the following three-point strategy for training independent consultants.
1. Define A Fit-for-Purpose Process For Ensuring Qualifications
GCP regulations and guidelines require that individuals are qualified to perform their assigned tasks. Yet, industry standard processes to ensure compliance with this requirement don’t work well for individuals contracted to perform one or more GCP tasks only when needed. A few examples of GCP tasks delegated to part-time consultants are:
- medical review and assessment of serious adverse events (SAEs) for clinical protocols/programs where few SAEs are expected/occur,
- vendor and clinical quality assurance auditing, and
- regulatory, computer system validation, medical writing, and process development and writing activities to support internal staff or small companies, when needed.
The qualifications of individuals are the primary concern for regulators, not whether they have completed every company training as required for internal employees. Global regulators have clearly relayed their support for practical compliance approaches to drug development. This supports following a logical and efficient process for determining if these professionals are qualified. Before such a process can be developed, the company must establish clear categories for GCP staff rather than continuing to lump them all together. The current documented policy for training is probably something like this:
All company employees, including contractors and consultants, shall be qualified by education, training, and experience to complete their assigned tasks.
Of course, everyone must be qualified; this is an appropriate policy. However, the process and documentation required to demonstrate the qualifications of permanent employees, full-time independently contracted staff, vendor employees, and part-time consultants can and should be different.
2. Identify And Require Appropriate Documentation of Part-Time Consultant Qualifications
Attempting to follow the same process and generate the same documentation using the same electronic learning management system (LMS) for these two scenarios has everyone moving in a circular path, sitting in meeting after meeting, wondering, “Why are we still talking about this?”
The trickiest part of the ongoing conversation seems to be agreeing on which internal regulatory, policy, and process training requirements should be assigned to part-time consultants, especially when the nuances of the LMS and cost come into play.
The minimum documentation required for a part-time consultant should be:
- A contractual agreement or statement of work that defines what the individual will do for the company.
- A professional and current CV that relays the individual’s education and experience that qualifies him or her to execute the tasks delegated.
For example, if you’re delegating clinical drug safety tasks to a consultant whose CV doesn’t include drug safety for clinical development, that’s an issue. Either you don’t have the right consultant, their experience isn’t well reflected in their CV, or their CV simply isn’t current. There are many overlapping functions in our industry. Many people don’t understand the complexities enough to realize that, for example, having a medical degree and 10 years of experience as a medical monitor doesn’t necessarily qualify a physician to advise on overarching clinical drug safety processes, including regulatory reporting. Likewise, 20 years of clinical investigator site auditing experience does not necessarily make a person qualified to assess or build your quality management system or clinical quality assurance program.
Ideally, a CV would include recent (within two to three years) GCP training. If the CV includes enough detail to demonstrate an obvious current understanding of GCPs, requiring the candidate to take company GCP training is not critical. If a person needs further training, then I suspect that they aren’t truly qualified to audit your GCP activities.
- A copy of any accreditations or certifications that are required, like a medical license, or those that contribute to their qualifications, such as a RQAP-GCP certification.
To maintain these types of certifications, professionals must complete continuous education. If they have a professional certification in their area of expertise, it’s likely they do not need to complete your company’s training on the topic. Many accredited professional consultants create training materials and teach on their areas of expertise.
- Lastly, documentation that they have trained on any company-specific policies and procedures that include activities and/or actions they are required to take.
I’ve seen far too many instances where companies do not require physicians hired to review SAEs to train on company policies and standard operating procedures (SOPs) because it incurs too high a cost. That is a slippery slope that oozes noncompliance. The physicians do not need to train on every quality system, corporate, and clinical policy and every SOP that exists; however, they must train on those that directly relate to the specific activities they execute or advise on. They also must train on updated versions of those documents.
Be sure to involve QA team members to help determine which company policies and procedures regulators would expect the consultant to understand. Your QA team members have a unique perspective; compliance is their area of expertise. Let them advise you, and then trust them.
3. Don’t Get Trapped In Your Learning Management System
All the best electronic LMSs are centered on role-based training, which is supported by global regulations and guidelines. These systems were designed for internal training. That works great for internal employees, but not so much for part-time consultants.
One way around this is to manage these consultants as vendors rather than employees when it comes to training. Gather and include the documentation as you would for a vendor. If you have an electronic quality management system that includes vendor qualification, set up a vendor category for these consultants. Enter their information, upload the documentation, and track it through that process rather than through your training compliance process.
You may be thinking that training documentation is in that system. Is it? Individuals can still read policies and SOPs you provide outside of your LMS. They can still document that they have read and understand them. The key is obtaining and retaining the documentation that supports their qualifications and ability to do what you’ve asked them to do. The QA vendor qualification/oversight process is a perfect fit for retention and tracking for this scenario.
The basic reason that regulations require that credentials are documented and that training occurs is to ensure that individuals are qualified to execute GCP tasks. It’s not productive or efficient to lump together all the scenarios that have emerged due to the decentralization of clinical trials. It is efficient and essential to define your approach and remain consistent throughout your organization.
About The Author:
Penelope Przekop is a corporate quality management expert. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharma companies, including Pfizer, Merck, Lilly, and Glaxo Smith Kline, and held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. She is the founder and CEO of PDC Pharma Strategy and serves as the Chief Compliance Officer for Engrail Therapeutics. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Przekop earned a BS in biology from Louisiana State University and an MS in quality systems engineering from Kennesaw State University. She is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women. Her new book, 5-Star Career: Define and Build Yours Using the Science of Quality Management launches in November 2021 from Productivity Press.