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- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee + (Glossary - ethics committee)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report + (Glossary - final report)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent + (Glossary - informed consent)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection + (Glossary - inspection)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product) + (Glossary - investigational product (synonym: study product))
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator + (Glossary - investigator)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure + (Glossary - investigator’s brochure)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor + (Glossary - monitor)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file + (Glossary - patient/subject file)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product + (Glossary - pharmaceutical product)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator + (Glossary - principal investigator)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol + (Glossary - protocol)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data + (Glossary - raw data)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event + (Glossary - serious adverse event)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor + (Glossary - sponsor)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation + (Glossary - validation)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data + (Glossary - verification (validation) of data)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness + (Glossary - witness)
- Reference:ICH ICH E6 Guideline R3 (2025) I + (I)
- Reference:ICH ICH E6 Guideline R3 (2025) II + (II)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II + (II)
- Reference:ICH ICH E6 Guideline R3 (2025) II 2.4 + (II 2.4)
- Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 + (II 7.4)
- Reference:ICH ICH E2A Guideline 1994 II A. 3. + (II A. 3.)
- Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction + (II B. Serious Adverse Event or Adverse Drug Reaction)
- Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe + (II B. Serious/Severe)
- Reference:INT ISPE - GPP Revision 3 (2015) II. + (II.)
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001 + (II. Advertising)
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002 + (II. Advertising)
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction + (II. Introduction)
- Reference:ICH ICH E9 Guideline 1998 III + (III)
- Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III + (III)
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV. + (III - IV.)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. + (III 2.)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. + (III 4.)
- Reference:ICH ICH E2A Guideline 1994 III A. 1. + (III A. 1.)
- Reference:ICH ICH E2A Guideline 1994 III A. 2. + (III A. 2.)
- Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. + (III A. ; IV.)
- Reference:ICH ICH E2A Guideline 1994 III B. - III C. + (III B. - III C.)
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. + (III B. 3.)
- Reference:ICH ICH E2A Guideline 1994 III E + (III E)
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III. + (III.)
- Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. + (III. A.)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2 + (III. Annex 3.17.2)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1 + (III. Annex 1 1)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7 + (III. Annex 1 1.2.7)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2 + (III. Annex 1 2)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 + (III. Annex 1 2.10)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 + (III. Annex 1 2.11)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 + (III. Annex 1 2.12.1 - 2.12.3)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 + (III. Annex 1 2.12.10)
