WE APPROVE |
WE ACKNOWLEDGE |
WITHOUT FEEDBACK |
Substantial Amendment (SA) (with Covering Expenditures) |
Investigator´s Brochure Update (as non-SA) |
CRF (Case Report Form) |
Non-substantial Amendment (without Covering Expenditures) |
Protocol Deviation Alert |
Information on the Commencement of the CT |
New version of Information for Patient/Informed Consent Form (IP/ICF) |
Notification of Quality Defect (additional information required) |
CT Annual Progress Report |
Amendment to IP/ICF |
Urgent Safety Restriction (additional information required) |
DSUR/SUSAR/SAE line listings |
Amendment to Pharmaceutical Documentation (including shelf-life ext., new stability data, CoA, …) |
Dear Doctor Letter (as non-SA) |
Information about completion, suspension or early termination of the CT |
Form for Customs Purposes |
Notification onTemporary Halt of CT |
Summary report on the CT |
Dear Doctor Letter (as SA) |
Restart of CT |
Amended Protocol |
Change of Sponsor |
Information on the death of subject |
Patient´s Diary, Questionnaires, Cards, … |
Change of Legal Representative |
SmPC Update (if IMP has MA) |
Insurance Certificates |
Change in labeling Medicinal Product |
|
Advertisement, Advertising Materials |
Investigator´s Brochure Update (if SA – e.g. change of RSI) |
Change in center/New center (required submission of CTA – xml + signed hardcopy) |
|
Restart of CT
|
Change in Investigator (required submission of CTA – xml + signed hardcopy) |
|
Fulfilment of Mandatory Notice |
Change in CRO/contact person (required justification and statement from former CRO and from new CRO (including new PoA); effective date of this change; required submission of CTA – xml + signed hardcopy |
Legenda:
IP/ICF - Information for Patient / Informed Consent Form
CoA - Certificate of Analysis
RSI - Reference Safety Information
CT - Clinical Trial
SmPC - Summary of Medicinal Product Characteristics
IMP - Investigational Medicinal Product
MP - Medicinal Product
CRO - Contract Research Organisation
SUSAR - Suspected Unexpected Serious Adverse Reaction
SAE - Serious Adverse Event
CTA - Clinical Trial Application
Clinical Trials Department
28. 5. 2014