APRIL 2001
Dear Editor,
I am writing to you about the ACDM course 'GCP in Reality' that I recently attended (29 November 2000)
I was unsure what to expect from a course about GCP and was apprehensive about what would occur. Would the presenters make us chant ICH-GCP guidelines at the front of the room like my teachers used to make me chant my times tables at school? I hoped not.
I have to say that I was pleasantly surprised. I came away from the course not with an in depth knowledge of every guideline ever written, but with a good overall understanding of how and why these guidelines exist. I am writing to you today to thank and give feedback to those that ran the course and also to give a brief overview to Newsletter readers that will hopefully encourage others to attend this course.
The course opened with some history of GCP and I was surprised at how recently this had been established. The main trigger being the drug Thalidomide in the 1960's that unexpectedly caused birth defects. This resulted in a thorough re-assessment of how new medicines were tested. It was only in the 1970's that guidelines for GCP were put together and only 10 years ago that ICH was initiated. At the moment ICH-GCP are only guidelines, only later this year will they be implemented as law in Europe.
We then discussed how to put ICH-GCP into practice, discussing audit trails and how all changes made should not obscure the original response, and should always be signed and dated. I particularly like the quote 'If you do not document it, it did not happen'.
The "use and validation of computer-ised systems" section reinforced the groups' knowledge of the importance of testing, back ups, SOP's, security and training. Remember that no one should be able to access a database until adequate training has been received, this includes auditors!!! With the amount of viruses travelling around the data management world via email (yes everyone knows everyone in this business!) companies have to be well equipped with virus protection software.
The course ended with some exercises where groups were presented with GCP related scenarios and had to come up with solutions. This is where we put into practice what we had learnt during the day. This to me was the most interesting part of the day as we had some great arguments in our groups about how we would deal with an accidental unblinding or cope with auditors' findings. It was here that the differences in company procedure became apparent. DCF, queries, discrepancies all mean the same thing but have different names at different companies.
I hope I have summarised very briefly the main objectives of the day. The course packs in a lot in one day. There is a lot of information to take on board (including lots of new acronyms to learn!) and a lot of extra reading to do after the course, but I think it was well pitched at its audience and very well organised. The speakers were clearly very knowledgeable about their topics and presented their information in a relaxed way. This together with the fact that the course is run with a small group encourages much interaction and I felt even the shyest person would not feel intimidated to speak up with their opinion.
I have tried to find something negative to say about the course, but have failed. Even the food was delicious, the location excellent and the coffee breaks a plenty.
Elizabeth Nuthall,
Roche Products Ltd
Response from the Chairperson,
ACDM Training Sub-Committee (TSC)
TSC members were very pleased to hear this feedback of our course - thank you! We would like to bring to everyone's attention the re-design of this course as featured in our 2001 programme of training courses. The course now has a new name - 'Staying Ahead of the Game' and will try to ensure those attending are able to keep up with latest quality and regulatory legislation that affect CDM in both Europe and the USA.
Current objectives of the course are to:
provide an overview of recent quality and regulatory legislation that affects CDM
consider the current status of MedDRA implementation throughout the industry
compare 21CFR11 with the European Electronic Signatures Directive
explore key aspects of the EU Data Privacy Directive from a Data Management perspective
provide an update on the status of electronic submissions across Europe and the US, considering the ICH Common Technical document and the challenge to current CDM practice
provide an update on the use of e-media solutions for archiving of documentation and paper storage requirements at investigator and pharma sites
We hope these topics will be of interest to ACDM members and that the revised course will prove to be valuable.
Gill Lawrence,
Chairperson, ACDM Training Sub-Committee