Safety & Pharmacovigilance

The documents to the right of the SOPs are documents that are associated with the SOP

TASC_SOP11v8	IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS	Pregnancy Notification Form Pregnancy Follow-up Form SAE Form AE Log
TASC_SOP15v6	PREPARING AND SUBMITTING PROGRESS AND SAFETY REPORTS IN CTIMPS (CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS) AND NON-CTIMPS	Development Safety Update Report Form
TASC_SOP37v5	ACCOUNTABILITY, RETURNS AND DESTRUCTION OF INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
TASC_SOP38v5	MANUFACTURING, ASSEMBLY, PACKAGING AND LABELLING OF IMPs IN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
TASC_SOP39v6	SUPPLY, TRANSPORT AND STORAGE OF IMP IN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
TASC_SOP43v4	FOR HANDLING PRODUCT RECALLS OF CLINICAL TRIAL INVESTIGATIONAL MEDICINAL PRODUCTS OR OTHER TRIAL RELATED DRUGS	IMP Recall/Alert Notice Recording form for product recalls or alerts affecting CTIMPs sponsored by UoD or NHST IMP Mock Recall Report