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 3.5.3: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document: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 | ||
| | |module=2 | ||
| | |unit=2.1.2 | ||
| | |scope=G | ||
| | |doc_part=3.5.3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00134-Eth-kom ++ TAG-00057-Com-deR | |||
|tags_display=[[Glossary:TAG-00152-Tri-gat|Trial master file]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00057-Com-deR|Competent authority]] | |||
|comment=Correspondence as essential trial documentation | |||
|content=3.5.3. Correspondence | |||
Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. This includes correspondence with ethics committees, data safety monitoring committee and regulatory authorities (confirming sponsor approval of processes, documents and decisions and the communication regarding issues that arise in the trial conduct and how they are dealt with). Similarly, electronic correspondence (e-mails and associated attachments between CROs, sponsor departments, investigator/institution) should be readily available and may be retained electronically. It should be ensured that both sent and received correspondence is filed in the TMF. One or more separate central repository may be used (e.g. for e-mail), as long as they are clearly defined as being part of the TMF (see section 3.2). Care should be taken regarding e-mail βchainsβ and attachments to ensure that relevant strands of conversations and their associated documents are maintained. For archiving of correspondence see section 6.3. | |||
}} | }} | ||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| 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 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/856758/ 2018
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) |
| Version / Revision | 06-Dec-2018 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/856758/2018
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 β Unit 2.1.2 |
| Scope | G |
| Document part | 3.5.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial master file, Documentation, Ethics committee, Competent authority |
Content
3.5.3. Correspondence Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. This includes correspondence with ethics committees, data safety monitoring committee and regulatory authorities (confirming sponsor approval of processes, documents and decisions and the communication regarding issues that arise in the trial conduct and how they are dealt with). Similarly, electronic correspondence (e-mails and associated attachments between CROs, sponsor departments, investigator/institution) should be readily available and may be retained electronically. It should be ensured that both sent and received correspondence is filed in the TMF. One or more separate central repository may be used (e.g. for e-mail), as long as they are clearly defined as being part of the TMF (see section 3.2). Care should be taken regarding e-mail βchainsβ and attachments to ensure that relevant strands of conversations and their associated documents are maintained. For archiving of correspondence see section 6.3.
