|What Surprises GCP Auditors the Most?
Polaris Compliance Consultants
Last month, I asked some of our most experienced GCP auditors the same question: What surprises you most about the audits you conduct? As it turns out, I was the one who was surprised.
Electronic Health Records as Source Data
In July, FDA finalized its 2016 draft guidance for using EHRs in clinical research. The guidance addresses data retention and record-keeping requirements, CRA/inspector access, non-certified EHRs, and Informed Consent provisions. When using EHRs as data source, study sites should confirm that their SOPs and data sharing agreements are in alignment with the guidance. CROs and Sponsors should ensure their Quality Data Management Plans address data transmission integrity and, among other things, document the manufacturer, model, and version of each EHR system used in the trial.
Bridging Research and Practice
University at Buffalo
Have you heard about the evolving field of Implementation Science? While most clinical researchers focus on drug development and regulatory approval, some focus on the transition from clinical trials to clinical practice. “To be in a trial, patients need to meet strict criteria and the treatment needs to be delivered with a very high degree of fidelity. This rigor is necessary [for the science]…but translating an innovation to the real world requires working with busy clinical teams and with diverse patients, who don’t necessarily fit the mold."
Not Your Typical Listsicle
At the FDA/Xavier PharmaLink conference in March, FDA reps presented their Top Ten GMP inspection citations for 2017
. Far from the usual laundry list of top findings, the discussion included some very useful explanation and analysis. Presenters were asked, “Of the violations we talked about today, which were the most egregious and could result in some sort of a regulatory action?” Can you guess which 3 violations the panelists identified?
GDPR for Clinical Research Data Processors
Under the GDPR, companies like Medidata whose systems process personal data have more at stake than most in the clinical trial world. Here, Medidata’s General Manager provides some specific documentation that internal and external compliance auditors will be looking for, namely (1) ISO/SOC certification for system security, (2) data accountability documents such as data maps and the Data Protection Impact Assessments, and (3) data protection clauses written into vendor contracts.
There's a New 'Celerate In Town
TransCelerate and BioCelerate have launched DataCelerate, a new platform that allows member companies to share de-identified subject-level trial data with each other. TransCelerate CEO Daliver Gill says that in many cases, access to the datasets allowed sponsors to conduct clinical trials with a lot fewer patients.
Say Hello to ICH Q13
What’s that? A new ICH guidance, you say? Give a big warm welcome to ICH Q13 (in 3 years).
Polaris Compliance Consultants News
- Do you want to understand computer systems validation better? Are you wondering where to start when developing a Part 11 compliance plan? Join Polaris expert Lisa Olson on Sept 11 for a 90-minute interactive webinar, conducted in partnership with the Life Science Training Institute.Subscribers to our newsletter receive a 10% discount on the registration fee. Use discount code POLARIS.
- We’re pleased to announce that Jean Noblin is our new Resourcing Manager. Jean’s career has included virology research, medical writing, change management, IP development, and resource management. With this strong background, Jean will be working behind the scenes, coordinating project managers and consultants to ensure we provide our clients the highest quality services possible.
- We'd also like to welcome Samir Handa, the most recent in a succession of talented interns we’ve had here at Polaris. Samir attends Wake Tech and is majoring in IT/Network Management. During his semester with us, Samir will be working with CIO Ty Tyson supporting our IT infrastructure and writing scripts to automate elements of our disaster recovery processes.
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