In a Research Minute, I have looked before at what makes a qualified clinical research professional1. And I challenged that, for example, making people repeat GCP training at arguably defined intervals, doesn’t actually make them more qualified.
In this instalment of In a Research Minute, I’m discussing the quality of the documentation of those qualifications, who is responsible for ensuring qualifications, and the proper documentation of this.
Everyone working in clinical research needs to maintain proper documentation of their qualification. Where the qualification is achieved through education, training and experience, proper documentation of all three is required. The typical documents that are used to document qualification are a combination of the CV and a training record, sometimes supported by training certificates. The training record typically used to document the required study-specific training, with the documentation of education, experience and non-study-specific training done through the CV.
Most important are the qualifications of the professionals that are involved in protecting the trial subjects as well as in the generation of the data that will result in reliable trial results. That’s the site staff! Everyone that has significant trial-related activities assigned to them needs to have properly documented qualifications.
The training records are, when they are indeed used, most often used correctly. Any trial-related training that is done is recorded, making the trial-specific part of the qualifications typically documented best.
Most of the time, the problem is with the research resumé. Providing the CV is too often approached as a tick-box activity, without properly considering why it’s part of the essential documents. As a result, often a professional CV is submitted, rather than a research resumé.
The professional CV will list education, no problem. Most of the time, documentation of training, and specifically GCP training, is in there too. Regularly not up-to-date though, in which case training certificates complete the set. But what is typically missing is the actual clinical research experience. How many trials were done in which capacity? What phases of trials were done? The CV is intended to demonstrate clinical research qualification. With ongoing clinical trials, for that reason, the CV may need occasional updating.
An often recurring question I get is how recent the CV needs to be, to be considered ‘current’. If you’re asking that question you’re not focussing on the purpose of the document. Some consider ‘not older than 2 years’ to be current. Well, if you’ve not done any trial work in those two years, it may well be. However, most will be working on trials on an ongoing basis. So every new trial deserves an up-to-date CV.
Another question is whether, when a trial is ongoing for several years, the CV needs to be renewed, say every two years, for it to remain current. On that, I want to go back to the intention of the document. When a research professional starts the trial qualified, what are the odds that, during the course of the trial, he or she is no longer qualified? Of course, when there is important new information that calls for training, documentation of that needs to be present. So for example, when ICH-GCP R2 came out, training was needed. And either the CV needed updating or the certificate of that training needed to be added. But renewing a signature on a CV during a trial, making it ‘current’ again, is doing a tick-box activity which is not adding to the purpose of why the document is collected.
Another aspect, on which I find there’s a discussion, is on what documentation needs to be where. I notice that a number of sponsors and CROs are collecting all CVs of all site staff listed on the delegation log. And I wonder why!
Let’s go back to the responsibilities, as they are outlined in ICH-GCP. The sponsor, and by proxy the CRO if involved, has the responsibility to ensure that qualified investigators and sub-investigators are selected to work on the trial (2, 5.6.1). That’s why, in paragraph 8.2.102, the CVs of investigators and sub-investigators are listed as having to be in the files of the sponsor and the site. But that’s only from the investigators and the sub-investigators.
The investigator has the responsibility to ensure that sufficient qualified staff is available for the foreseen duration of the trial and needs to ensure that they are trained for their trial-related duties (2, 4.2.3 & 4.2.4). You could, therefore, argue that documentation of the qualifications of the site staff should be available in the site file, to demonstrate that the investigator lived up to that requirement. This, however, is purely an argumentation, because this documentation is not considered essential documentation, according to ICH-GCP chapter 8. However, as an auditor, I do look for evidence that the investigator has lived up to this requirement. If a site is maintaining the CVs in a separate file, non-trial-specific, available for monitoring and auditing, I still advise that a copy of those are kept in the trial files of the site. But that is so that it is included in the documentation that is archived so that, in case of an inspection in the future, there is documentation of the qualifications of the site staff available.
When sponsor or CRO collect CVs of all site staff, though, I start to ask questions why. There just is no argument for this collection of personal information. Responses vary from ‘we do this as a result of audit findings’ to ‘we have to, to be GCP-compliant’. Both arguments don’t hold water. If, as a result of a finding or comment of an auditor, a choice is made to change standard practice, this choice needs to be made because the argument behind it is supported. And the same goes for the GCP argument. ‘Because GCP says so’ is never a reason to do it. If you cannot explain why GCP says something, figure that out first, and then do it for that reason. IF GCP says it… Because that is not always the case! And in this case, GCP says nothing about the sponsor needing to collect the CVs of all site staff.
Most often, however, the argument given by sponsor or CRO representatives is that they need to be able to demonstrate that qualified site staff is working on their trials. And this is just not true. The sponsor only needs to be able to demonstrate this for their investigators and sub-investigators. The investigators need to be able to demonstrate having ensured that qualified staff is available. That means that CV’s of site staff need to be available on-site, and as argued above, preferably in the site file.
Although it’s not the sponsor’s or CRO’s responsibility to ensure qualified site staff, they do have to be able to verify that the investigator ensured this. To be able to do this verification, the sponsor representative can monitor this during a site visit. Collecting the CV’s for the trial master file is not needed.
In the current time, when privacy regulation is getting more and more tight, it just can not be justified to collect personal information of people without a clear reason, and without actually doing anything with it. They’re just being filed and archived. This practice needs to be reconsidered.
Of course, if there is a regulatory requirement, or an inspectorate expectation in specific countries, that CVs of all site staff are collected by the sponsor or the CRO, this would provide the justification for this collection. However, this is not a standard regulatory requirement.
In summary, ensure the availability of research resumés, and be considerate about where personal information is stored and for what reason. This should reflect the responsibilities as ICH-GCP has outlined them.
1 In a Research Minute: A Qualified Professional