Menu

Trial Management

 

The documents to the right of the SOPs are Documents Associated with the SOP

 TASC_SOP TM007v7.0
RECEIVING INFORMED CONSENT FROM POTENTIAL PARTICIPANTS IN CLINICAL RESEARCH
Doc Ref 009 v7.0 Informed Consent Form    
 Doc Ref 117 v2.0 PIS Template                                                                        
                                                                                         
 

 

TASC_SOP TM012v5.0
ESTABLISHING IDENTITY OF PARTICIPANTS IN CLINICAL RESEARCH                                            
 
 
 TASC_SOP TM013v8.0
ARCHIVING CLINICAL RESEARCH DATA
  Doc Ref 111 v2.0  Guidance: Preparing Clinical Research Studies for Archive
 Doc Ref 112  v3.0  Clinical Research Study Archiving Destruction Certificate
 Doc Ref 120 v1.0 Recall from Archive Request Form
 Doc Ref 121 v1.0 Clinical Research Study Archiving Plan
 Doc Ref 122 v2.0 Clinical Research Study Archiving Record Form
 
TASC_SOP TM014v7.0                           
WRITING A PROTOCOL TO GOOD CLINICAL PRACTICE FOR CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS                                                             
 
 
  
   
 Doc Ref 98 v6.0 NCTIMP Protocol Template

 

 
 TASC_SOP16v6.0 
CLOSURE of CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS   

 

 
 
TASC_SOP TM018v6.0  
TRIAL SET-UP IN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS               
Doc Ref 007 v3.0 Trial Master File (TMF)/Investigator Site File (ISF) Specific SOP Log
 Doc Ref 018 v8.0 TMF Index
Doc Ref 019 v5.0 ISF Index
Doc Ref 057 v7.0 Delegation Log
 Doc Ref 071 v4.0 Participant Randomisation Log
Doc Ref 076 v4.0 Screening Log
Doc Ref 096 v9.0 SF Index
 

 

 TASC_SOP19v8.0
PREPARING AND MAINTAINING CASE REPORT FORMS (CRFs) FOR USE IN CLINICAL RESEARCH
Doc Ref 057 v7.0 Delegation Log
  
 

 

TASC_SOP TM023v5.0    
COMPLETION OF DELEGATION LOG
Doc Ref 057 v7.0  Delegation Log
 

 

 

 

  TASC_SOP45v6.0
ESTABLISHING AND MAINTAINING A TRIAL MASTER FILE, INVESTIGATOR SITE FILE AND PHARMACY SITE FILE IN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
 
Doc Ref 018 v8.0 Trial Master File Index
Doc Ref 019 v5.0  Investigator Site File Index
Doc Ref 118 v2.0  Pharmacy Site File Index
 
   
Doc Ref 107 v3.0 NCTIMP Study Master File Index
 

© University of Dundee and NHS Tayside Health Board, 2018

TASC do not permit the copying of SOPs contents and logos without reference to source of ownership.

Recommended by us