You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now almost five years later, many sites and Sponsors have explored and implemented the electronic filing capability.
Topics: ICH GCP, Electronic Regulatory Binders
Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice. The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland). This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996.
Topics: Good Clinical Practice, ICH GCP, Draft Guidance, FDA
In a perfect world, all the data needed to complete a clinical trial case report form would be found in the medical record. Unfortunately, we do not live in a perfect world!
Topics: ICH GCP, FDA Warning Letters, Worksheet, Source Documentation
As we enter 2013, how often do you find yourself in a city different from your relatives? In an emergency, many hospitals have policies and procedures to obtain consent for treatment from your legally authorized representative by phone, email or fax. When a research subject is unable to participate in the informed consent process, and their Legally Authorized Representative cannot physically sign for them, should this automatically exclude them from participating in clinical research? Can a discussion via video chat or phone, well documented, satisfy the requirements?
Topics: ICH GCP, CFR Part 50, Informed Consent, Consent via Phone
The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research. The regulations, CFR part 50 also cover the importance, rules and process of informed consent.
Topics: Informed Consent Process, ICH GCP, CFR Part 50