Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
From GxPlex
| Document information | |
|---|---|
| Reference | WHO WHO - HANDBOOK
FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - HANDBOOK
FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) |
| Version / Revision | 2005 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process | HM | Overview of the Clinical Research Process | EN | Key trial activities include:
1. Development of the trial protocol […] 2. Development of standard operating procedures (SOPs) […] 3. Development of su… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22 | G | Page 22 | EN | [...]
In general, all individuals, including healthy volunteers, who participate as research subjects should be viewed as intrinsically vulnerable. W… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 | G | Page 28-29 | EN | What information should be included in a study protocol?… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 | G | Page 31 | EN | When is unblinding of the trial by the investigator permissible? How should unblinding be accomplished (in those situations where it would be allowed)… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44 | G | Page 44 | EN | What about financial reimbursements to research subjects? Financial reimbursements to subjects are distinct from any benefi ts contributing to the ris… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61 | G | Page 60-61 | EN | Who may administer informed consent? The person who conducts the consent interview should be knowledgeable about the study and able to answer question… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78 | G | Page 78 | EN | What is an Independent Data and Safety Monitoring Board (DSMB, also known as an independent Data Monitoring Committee [DMC])? An independent data and … |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94 | G | Page 94 | EN | [...] What is meant by “data quality”? What is meant by “data integrity”? How are the terms related, and how are data quality and integrity achieved w… |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP | G | WHO Principles of GCP | EN | WHO Principles of GCP
Principle 1: Research involving humans should be scientifi cally sound and conducted in accordance with basic ethical principl… |
