Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline
- Annex 2 R3 Annex 2 |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline
- Annex 2 |
| Version / Revision | R3 Annex 2 |
| Status | Draft |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2 | G | Annex 2 2.2 | EN | 2. INVESTIGATOR
[...] 2.2 Informed Consent Considerations [...] 2.2.1 Informed consent may be obtained remotely, where appropriate. When informed cons… |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 | G | Annex 2 2.3 | EN | 2.3 Investigational Product Management Various approaches to investigational product management (i.e., supply, storage, dispensing, administration, r… |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 | G | Annex 2 2.3.2 | EN | 2.3.2 Certain documentation and processes already used in the institution/healthcare centre may be sufficient for the management of the investigationa… |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 | G | Annex 2 2.4 - 2.5 | EN | 2.4 Investigator Oversight
[…] 2.5 Safety Assessment and Reporting For the safety monitoring of individual trial participants (see Annex 1, section 2.… |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 | HM | Annex 2 3 | EN | 3. Sponsor
3.1 Engagement and Communication […] 3.1.1 Engaging patients, patient advocacy groups and their communities, as appropriate, can help ensur… |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction | G | Annex 2 Introduction | EN | [...] Data may be broadly classified into two types, and a trial may make use of both types of data (i.e., data generated specifically for the trial (… |
