Jacksonville Public Library
Clinical trials + Reporting
Type
http://bibfra.me/vocab/lite/Concept
Label
Clinical trials + Reporting
Name
Clinical trials + Reporting
Focus
Clinical trials + Reporting
Sub focus
Reporting
Clinical trials
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Incoming Resources
Subject of
8
Guidance for industry, M4, the CTD, general questions and answers
Guidance for industry, E2BM data elements for transmission of individual case safety reports
Guidance for clinical investigators, sponsors, and IRBs, adverse event reporting to IRBs : improving human subject protection
Guidance for industry, granularity document : annex to M4, organization of the CTD
Guidance for industry, submitting marketing applications according to the ICH-CTD format, general considerations
Revision of the ICH guideline on clinical safety data management, data elements for transmission of individual case safety reports
Guidance for industry, E2B(M), data elements for transmission of individual case study reports, questions and answers
Guidance for industry, M4, the CTD, efficacy questions and answers
Outgoing Resources
Focus
1
Clinical trials + Reporting
Sub focus
2
Reporting
Clinical trials
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