Overview of documents, which are approved/acknowledged/left without any feedback by Institute on the field of Clinical Trials

Overview of possible ways of response of Institute to documents, which are submitted during Clinical Trial of human medicinal products to Clinical Trials Dpt.   

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