GCP Workshop 1718 September 2001 Munich, Germany

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GCP Workshop17-18 September 2001 (Munich,
Germany)

• Breakout Session 1
• Standard Operating Procedures
• Recommendations
• Chair M. Pott
• Rapporteur M. Moos

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1.MANDATE

• Define SOPs
• Identify SOPs
• Propose SOP updating process
• Reflect on availability to all parties

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2. DEFINE SOPs

• 2.1 Procedural SOPs common to all studies
• SOP is required to define the components and
  updating of an SOP
• General SOPs
• For clinical studies
• 2.2 Technical SOPs specific to each study
• Covering specific techniques
• Not further discussed

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2.1 Procedural SOPs - General

• An SOP for SOPs, to define company procedure
• Responsibilities
• Who writes and who signs the SOP?
• Who updates? When and how? Consultation, input
  from operators?
• What language(s)?
• Distribution and retrieval of previous versions
• Training, communication pathway
• Appointment of qualified staff, training SOP
• Archiving SOP
• Auditing SOP

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2.1 Procedural SOPs for clinical studies

• The need for the following SOPs was identified
• Organising a clinical study (described on slide
  7)
• Selection of investigator and site
• Preparation of protocol
• Informed consent form for animal owner
• Data handling
• Contracts (compensation for animal owner, legal
  issues)
• Site visits (before, during and after the study)
• Preparation of final study report
• Investigational veterinary drug procurement,
  shipment, storage, handling, accountability,
  disposal
• Adverse event reporting (investigator to
  Sponsor/Monitor)

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3. COMPONENTS OF AN SOP

• Title, author, date, validity date, version,
  update frequency
• Define responsibilities
• Define audience and language(s)
• Distribution list
• The procedure description itself

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4. SOP ORGANISING A CLINICAL STUDY

• What should it contain?
• Follow structure of VICH guideline?
• Justification for study
• Which studies should be GCP
• Define responsibilities
• Format of monitor compliance report
• Control of study documentation
• Communication, records
• QC and confirming compliance
• Report writing