Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6

Document Information

Document information
Reference	ICH ICH E6 Guideline R3 (2025)
Validity area	ICH
Scope(s)	HM
Document name	ICH E6 Guideline
Version / Revision	R3 (2025)
Status	Current
Document type	International guideline
Language(s)	EN
Description	GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	G
Document part	III. Annex 1 3.6
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Types of agreements between sponsor, investigator and service providers

Text

3.6 Agreements 3.6.1 Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data monitoring committee (IDMC), adjudication committee) involved with the clinical trial should be documented prior to initiating the activities.

3.6.2 Agreements should be updated when necessary to reflect significant changes in the activities transferred.

3.6.3 The sponsor should obtain the investigator’s/institution’s and, where applicable, service provider’s agreements:

(a) To conduct the trial in accordance with the approved protocol and in compliance with GCP and applicable regulatory requirement(s);

(b) To comply with procedures for data recording/reporting;

(c) To retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution or, where applicable, the service provider that these records are no longer needed, whichever is longest;

(d) To permit monitoring and auditing by sponsors, inspections by regulatory authorities (domestic and foreign) and, in accordance with applicable regulatory requirements, review by IRBs/IECs, including providing direct access to source records and facilities, including to those of service providers.

3.6.4 Any of the sponsor’s trial-related activities that are transferred to and assumed by a service provider should be documented in an agreement. The sponsor’s trial-related activities that are not specifically transferred to and assumed by a service provider are retained by the sponsor.

3.6.5 The sponsor should provide information to the investigator on any service provider identified by the sponsor to undertake any activities under the responsibility of the investigator. The responsibility for such activities remains with the investigator (see section 2.3.1). […]