TASC SOPs and templates: Pharmacovigilance and Investigational Medicinal Products

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

SOP37 

Accountability, Returns and Destruction of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP037

SOP38 

Manufacturing, Assembly, Packaging and Labelling of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP038

SOP39 

Supply, Transport and Storage of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP039

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

SOP65 

Preparing and Submitting Development Safety Update Reports (DSUR) for Clinical Trials of Investigational Medicinal Products (CTIMP)

• TASC SOP065‌
• Doc Ref 099 DSUR

SOP68 

Reporting Urgent Safety Measures for Clinical Trials of Investigational Medicinal Products (CTIMPS)

• TASC SOP068