Whitehall Training’s US GCP course has received a major update – we look at just what has changed since it's last major update, just over two years ago…
To paraphrase ex UK Prime Minister, Harold Wilson, “two year’s is a long time in good clinical practice.” As those who avidly follow FDA guidelines – it’s a doubly short time in US GCP!
One feature of the new course is a series of helpful videos to provide background information on some of the more tricky areas – such as risk-based monitoring – as well as broad introductions to topics such as how the FDA approval process works.
Some of the other new additions are…
FDA Inspection Data dashboard…
Since the last update, The FDA has released its Data Dashboard - a tool to share inspectional, compliance and enforcement related data in easily understood graphical formats. It is intended for a variety of inspections including clinical trial FDA inspections.
Users can look at inspection data within the graphical formats for a more detailed view and to export the graphs and data. The datasets and data include the Inspection Database and selected data elements from the compliance and enforcement related information on FDA.gov.
Guidance for IRBs, Clinical Investigators, and Sponsors IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed…
In August 2013, The FDA issued its final guidance on this, subject - I’m not going to write it out again! It affects everyone who conducts or has oversight of biomedical research, responsibility for ensuring that the research complies with applicable laws and regulations, and that risks to subjects are minimized.
In other words, pretty much everyone to whom GCP rules apply.
The sponsor still has overall responsibility for selecting investigators and sites, as well as determining if an investigational new drug application (IND) or investigational device exemption (IDE) is required. The guidance clarifies the role of IRBs and to encourages all parties to work together in order to protect the rights and welfare of study subjects.
One month later, the FDA also published its guidance on when an IND is not needed.
This guidance covers a risk-based approach for monitoring activities that focuses on critical study parameters and relies on a combination of factors to oversee a clinical trial effectively. This was introduce raise the standards of monitoring and is a major departure from carrying out 100% source document verification (SDV). It also promises to reduce monitoring costs.
The FDA is also encouraging centralised monitoring, which it defines as “a remote evaluation carried out by sponsor personnel or representatives (e.g., clinical monitors, data management personnel, or statisticians) at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring processes can provide many of the capabilities of on-site monitoring as well as additional capabilities.”
An example of centralised monitoring given in the guideline concerns the verification of informed consent. Why verify the original signature on each consent form at the site when they can be done centrally?
The Monitoring Plan…
The FDA recommends that each trial has a monitoring plan tailored to its individual subject protection and data integrity risks, identifying the various methods to be used, and the rationale for each trial.
The plan should identify the various methods intended to be used and the rationale for their use. If sponsors intend to rely heavily on centralized monitoring practices, they should identify, in the monitoring plan, when one or more on-site monitoring visits would be appropriate.
The FDA is making several changes to the way in which informed consent is handled.
The FDA is replacing its 1998 informed consent guidance sheet and in July 2014 it published the draft version of its replacement.
The draft guideline consolidates guidance from a number of Information Sheets and other draft and final guidance documents-providing a comprehensive guide to the regulatory requirements for informed consent for research under FDA jurisdiction. It also considers number of additional topics about the informed consent process including: Review of patient records, Children as subjects, and Recommendations on obtaining informed consent from non-English speaking subjects.
In November the same year, the FDA clarified its rules on emergency treatment where consent is not possible, stressing that sponsors must seek permission from the patient’s family to continue any trial started without consent and must allow patients to opt out once they are conscious.
The updated FDA Manual of Policies and Procedures (MAPP) for handling emergency exceptions replaces a 2003 version. It includes a new checklist explaining how FDA agency staff will review and approve emergency research and listing every element that needs to be included in the application and protocol.
This April, The FDA responded to the growing trend of providing electronic information to trial participants with its draft guidance on the use of electronic informed consent (eIC) in clinical trials. The emphasis of the guidance is prompting the right questions to ask when considering using eIC procedures.
Other changes in the course include:
- revised information on the use of “exculpatory language” in informed consent;
- Q&As covering charging for investigational drugs under an IND; and
- Enrichment strategies to support approval of drugs / Personalised Medicine development.
Of course, things never stand still.
The consultation on the ICH GCP guidance addendum finishes in a couple of months – however, you can be sure that Whitehall training will keep you fully up to date with all you need to know regarding Good Clinical practice – wherever you are!