coding adverse events - FDA.COMs Community Forums

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Post: coding adverse events (Topic#3470)

Jelf
Beginner
Posts: 1

01-15-07 05:04 AM - Post#3785

Our study is not using a standard medical dictionary (ie MedDRA), instead the team created a short list of expected adverse events. As we analyze our data we're now faced with a gigantic number of "Other" AEs and the possibility of expanding our code list (dictionary). If we change our AE dictionary mid-study are there any pot holes to watch out for?

Thank you for offering your perspective.

John
John Cuspilich, Sr. Consultant
Posts: 229
John

05-24-07 05:47 AM - Post#4001

In response to Jelf

Yes, most definitely,

You must ensure that the custom system has met validation and compliance requirements in accordance:
1. 21 CFR Part 11
2. General Principle of Computer System Validation
3. Computerized Systems Used In Clinical Trials 2004
4. Computerized Systems Used In Instigations 2007
5. ICH E6
Procedural controls are properly in place, i.e.
1. SOPs on Data Updates on master files, i.e. database, external dictionaries, etc…
2. SOPs on Change Controls in existing records
3. Validity of dictionary terms and acceptability of use
4. QA/QC Procedures for conducting reviews and qualifications of terms and use of

Sincerely,
John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc.
jcuspilich@auditing.com
jcuspilich@fda.com
856-596-2333 - 866-GXPNews