Paul Meng (The Medical Pharmaceutical
Research Center, Vienna, Austria) Josef Kolman (The Medical Pharmaceutical Research
Center, Vienna, Austria) Graeme Scott (Scotia Pharmaceuticals Ltd, Stirling, Scotland,
UK) Clinical Research - Phases of a Clinical Trail, Clinical Trial Design, History
and Development of GCP. Good Clinical Practice - What is It? SOPs. Organization
of Clinical Trials - Pharmaceutical Company as Sponsor, Investigator as Sponsor,
Working with Contract Research Organisations. Followed by 33 SOPs and Checklists
Ranging from: SOP1 - Study Organisation and Planning, SOP 5 - Protocol Validation.
SOP 11 -Indemnity, Compensation and Insurance. SOP 14 - External Testing of Samples.
SOP 24 - Study Medication, Drug Accountability. SOP 33 - Audits and Inspections.
FDA Regulations Concerning Clinical Trials