TASC SOPs and templates: Pharmacovigilance and Investigational Medicinal Products
TASC has developed a library of SOPs and templates for the Pharmacovigilance and Investigational Medicinal Products category
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SOP11 - Identifying, Recording and Reporting Adverse Events for Clinical Trials of Investigational Medicinal Products (CTIMPs)
- TASC SOP011
- Doc Ref 058a Pregnancy Notification
- Doc Ref 058b Pregnancy Follow-up
- Doc Ref 086 AE Log
- Doc Ref 129 RSI
- Tayside Pharmacovigilance System
SOP15 - Preparing and Submitting Annual Progress Reports for Clinical Research
SOP37 - Accountability, Returns and Destruction of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products
SOP38 - Manufacturing, Assembly, Packaging and Labelling of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products
SOP39 - Supply, Transport and Storage of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products
SOP43 - Handling Product Recalls of Clinical Trial Investigational Medicinal Products or Other Trial Related Drugs
- TASC SOP043
- Doc Ref 016 Drug Product Recall Notice
- Doc Ref 094 Recording Form for Product Recalls or Alerts
- Doc Ref 095 IMP Mock Recall Report