FDA Provides Important Clinical Trials Guidance

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Patrick Stone, President, TradeStone QA

In the age of electronic documents and electronic signatures, the FDA is still defining and providing guidance for 21 CFR Part 11 concepts it began in 2003.  It seems we all really need to catch up.

Now that FDA provides small business webinars and blogs about “the most pressing public health issues of the day”, it is refreshing to note that FDA does not deem all electronic records as regulated; however with human clinical trials, most if not all records are reviewable (investigator discretion).

Basic concepts like hybrid records (paper based, e-records) and meta-data (audit trail data-points) should be well defined by now and not mysterious to industry.  Enforcement discretion still applies for most Part 11 electronic review by FDA investigators.

The new risk based approach will need to be well documented and defined before approval is granted by the respective review division.  In 2007, FDA provided the most up to date guidance and current thinking on computer systems used in human clinical trials.

The three main concepts in this risk based approach are:
  1. Subject protection
  2. Human subject rights, and
  3. Data integrity.

Once you can establish and document these three risk based controls you are ready to begin your clinical trial. The risk based approach continues throughout all phases of your clinical trial.

For clinical trials the FDA designates three tiers of data:
  1. Data entry
  2. Data review (PI or monitor)
  3. Data processing including transfer to FDA for your application.

Companies conducting clinical trials in the all-electronic environment with e-patient source, e-case report forms, and scanned regulatory records may find that costs go down. You have spent multi-millions in assets to implement validated e-systems so now you may use “alternative monitoring” methods for your monitoring controls.

Human clinical trials can be monitored from a desk if your monitoring plan is deemed acceptable to the review division. You do not necessarily have to pay travel expenses for multi-site monitoring anymore. Here is the game changing draft guidance for “Oversight of Clinical Investigations  A Risk-Based Approach to Monitoring” and I have also included the link for the 2012 Small Business webinar “Electronic Source Documentation in Clinical Trials” here.

There’s more to this subject and we’ll revisit it again.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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