GCP Workshop 1718 September 2001 Munich, Germany

1
GCP Workshop17-18 September 2001 (Munich,
Germany)

• Breakout Session 3
• Study Documentation
• Recommendations
• Chair J. Ashley-Smith
• Rapporteur J. Braidwood

2
MANDATE

• Management of the large quantity of data
• Data required to reconstruct a study Study
  Master File
• Multicentre studies data
• Archiving data
• Data entry is direct capture the optimal way?

3

• Data traceability and validation
• Trial / data amendments
• Use of eCRFs raw data / final report
• How to deal with foreign language data?

4

• Agenda
• Protocol
• Data entry
• Final study report
• Archiving
• Not a list of what to do - a collection of
  observations
• There are good guidelines available or pending!

5
1. PROTOCOL

• VICH Guidance viewed as comprehensive more
  detailed than previous
• Protocol review by regulators
• Contributed by FDA?
• Encouraged by some member states (e.g. Germany).
  Sweden requires dialogue.
• Limited uptake of scientific advice from EMEA
  (expensive, can be slow, used extensively for
  human medicines especially for new technologies)

6
1. PROTOCOL (continued)

• Amendments
• Must have signed amendments as part of Final
  Study Report
• Locally signed site-specific protocols plus a
  master protocol acceptable, but require
  justification

7
1. PROTOCOL (continued)

• Statistical design in the protocol is an
  improvement
• Interim analyses which has been pre-planned can
  allow change in statistical approach (if
  justified)
• Appropriate protocol amendment required to
  justify changes in statistical methods
• It helps to use a statistician!

8
AGENDA

• Protocol
• Data entry
• Final study report
• Archiving

9
2. DATA ENTRY

• Electronic data capture rarely used
• Potential in small animal studies
• May be difficult, costly
• Specialised software required e.g. to avoid
  data manipulation and show audit trail
• Regulatory Authorities geared to paper
  submissions, but may change (CVMP is paperless a
  first for the vets!)

10
AGENDA

• Protocol
• Data entry
• Final study report
• Archiving

11
3. FINAL STUDY REPORT

• The MOST important regulatory document
• Time spent here can determine success
• May represent a huge investment
• Often prepared under time pressure
• EMEA will only accept English
• Consider appropriate English mother tongue
  reviewer
• Clear presentation
• Use graphs, clear titles, be succinct

12
3. FINAL STUDY REPORT (cont.)

• Raw data supply suggestions
• Some regulators may prefer complete data
• This may result in fewer questions
• Generally supply a summary of the raw data
• If in doubt supply it!
• Supply of raw data (or otherwise) is an issue of
  judgement, and may vary on a case by case basis

13
3. FINAL STUDY REPORT (cont.)

• Contacts
• For in-house studies (e.g. dose confirmation) may
  use minutes of meetings
• Dont discuss over lunch!!
• Generally easier for the Monitor
• Suggest draft contact reports are sent to the
  Investigator for signature

14
AGENDA

• Protocol
• Data entry
• Final study report
• Archiving

15
4. ARCHIVING

• Generally not feasible for practitioners
• Usually transferred to Sponsors secure archive
• Scanned raw data with electronic signatures is
  adequate