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List of results

• Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18  + (GUIDELINE 18)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19  + (GUIDELINE 19)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary  + (Glossary)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements  + (Glossary - 1.5 Regulatory requirements)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy  + (Glossary - Double-Dummy)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout  + (Glossary - Dropout)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)  + (Glossary - Good Clinical Practice (GCP))
• Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC  + (Glossary - IDMC)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event  + (Glossary - adverse event)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction  + (Glossary - adverse reaction)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial  + (Glossary - audit of a trial)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF)  + (Glossary - case -report form (CRF))
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial  + (Glossary - clinical trial)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases  + (Glossary - clinical trial Phases)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product  + (Glossary - comparator product)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract  + (Glossary - contract)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO)  + (Glossary - contract research organization (CRO))
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment  + (Glossary - escape treatment)
• 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.)