Property:DocName
From GxPlex
Full name of the regulatory document.
G
Making changes to a research study to manage the impact of COVID-19 +
Medicines and Medical Devices Act 2021 +
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Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 +
NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS
FOR DCTD (CTEP AND CIP) INDs AND IDEs +
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NHS: Records Management Code of Practice +
U
NIH -
SCORE Manual +
NIH -
SCORE Manual: Appendix Source Documents Requirements +
NIH - Glossary +
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NIHR - National Institute for Health and Care Research +
National Health Service Act 2006 +
I
Nuremberg Code +
A
Question - BASG +
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Recognized Consensus Standards +
Recognized Consensus Standards - ISO 14155 +
E
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 +
Recommendations of the expert group -
Risk proportionate approaches in clinical trials +
Regulation (EC) No 1223/2009 - Cosmetic Products +
Regulation (EC) No 178/2002 - Food Safety +
EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 +
Regulation (EC) No 726/2004 -
authorisation and supervision of medicinal products for human use +
Regulation (EU) 2016/679 (GDPR) +
Regulation (EU) 2017/745 - Medical Device Regulation +