Pages that link to "Glossary:TAG-00148-Con-rsc"
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The following pages link to Glossary:TAG-00148-Con-rsc:
Displaying 15 items.
- Glossary (â links)
- Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 (â links)
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations â A Risk-Based Approach to Monitoring Aug-2013 VI C. (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9 (â links)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify (â links)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution (â links)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit (â links)