Amendments to clinical trial application (CTA)
Rethinking trials: the pros and cons of protocol amendments - PMLiVE
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2 - PDF Free Download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
NOTICE OF SUBSTANTIAL AMENDMENT
Clinical trials in the EU - Laura Pioppo
Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent au
AMENDMENTS
EU's Clinical Trials Regulation and portal goes live 31 January
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research | PLOS ONE
Substantial Amendments
How to Address—and Overcome—Operational Challenges in Master Protocol Studies
Guide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP) Health Products Regulatory Authority and National
Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Trials | Veeva
CLINICAL TRIALS GUIDANCE
Guidance for the Submission and Conduct of Clinical Trials (CT) with Medicinal Products - PDF Free Download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
Assessment of substantial amendments at the MPA
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
AMENDMENTS
Research Study Amendments
1 V1.1, 30-05-2018
Declaration of the End of Trial Form (cf. Section 4.2.1 of the Detailed guidance on the request to the competent authorities for
Amendment to an authorised clinical trial– step by step
