1. Name of service Approval for the substantial amendment (to a clinical trial on a medicinal product for human use) 2. Recipien
Clinical trials in the EU - Laura Pioppo
Amendments to clinical trial application (CTA)
How to Address—and Overcome—Operational Challenges in Master Protocol Studies
Time lines for CTA - Paul-Ehrlich-Institut
The Art of doing Clinical Regulatory well - Real Regulatory
Declaration of the End of Trial Form (cf. Section 4.2.1 of the Detailed guidance on the request to the competent authorities for
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
Acknowledging Cycle Time Impact from Protocol Amendments
UW BRIEF VAN 20
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
Substantial Amendments
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
AMENDMENTS
NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AN
Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Trials | Veeva
substantial_amendment_notification_form
The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research | PLOS ONE
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
Guide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP) Health Products Regulatory Authority and National
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2 - PDF Free Download
During your study:
EU's Clinical Trials Regulation and portal goes live 31 January
Amendment to an authorised clinical trial– step by step
1 V1.1, 30-05-2018
Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic Date: 25.3.2020 Versio
Research Study Amendments
AMENDMENTS
