SOP11 - Identifying, Recording and Reporting Adverse Events for Clinical Research

• TASC SOP011 v12
• Doc Ref 058a Pregnancy Notification v5
• Doc Ref 058b Pregnancy Follow-up v5
• Doc Ref 072 SAE Form v17
• Doc Ref 086 AE Log v5

SOP15 - Preparing and Submitting Reports for Clinical Research

• TASC SOP015 v11‌

SOP37 - Accountability, Returns and Destruction of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP037 v8

SOP38 - Manufacturing, Assembly, Packaging and Labelling of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP038 v8

SOP39 - Supply, Transport and Storage of Investigational Medicinal Products in Clinical Trials of Investigational Medicinal Products

• TASC SOP039 v9

SOP43 - Handling Product Recalls of Clinical Trial Investigational Medicinal Products or Other Trial Related Drugs

• TASC SOP043 v8
• Doc Ref 016 Drug Product Recall Notice v2.0
• Doc Ref 094 Recording Form for Product Recalls or Alerts v3.0
• Doc Ref 095 IMP Mock Recall Report v2.0

SOP65 - Preparing and Submitting Development Safety Update Reports (DSUR) for Clinical Trials of Investigational Medicinal Products (CTIMP

)

 

• TASC SOP065 v1‌
• Doc Ref 099 DSUR v4.0

 

 

 

 

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