ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

about the trial and follow the current approved protocol and other protocol-related documents, such as the current Investigator’s Brochure and relevant information related to the investigational product.

(c)

Confirming that the investigator is maintaining the essential records (see Appendix C).

(d)

Confirming that informed consent was obtained before participation in the trial (see section 2.8) for trial participants at the site.

(e)

Determining whether adverse events are appropriately reported within the time periods required by the protocol, GCP and the applicable regulatory requirement(s).

(f)

Confirming the protocol requirements for source records and the site’s location of such data.

(g)

Verifying that the blinding is maintained, where applicable.

(h)

Reviewing and reporting the participant recruitment and retention rates.

(i)

Confirming that the investigator provides the required reports, notifications or other information in accordance with the protocol and trial procedures. Confirming the arrangement for the retention of the essential records and the final accountability of the investigational product (e.g., return and destruction or alternative disposition, if appropriate) during site close out activity.

(j)

3.11.4.5.3

Monitoring of Investigational Product Management

(a)

Confirming, for the investigational product(s):

(i)

That storage conditions are acceptable and in accordance with the storage requirements specified in the protocol or other relevant documents;

(ii)

That supplies are sufficient throughout the trial and are used within their shelf life;

(iii)

That the correct investigational product(s) are supplied only to participants who are eligible to receive it at the protocol specified dose(s) and, where appropriate, in accordance with the randomisation procedures; That the participants, investigator, investigator site staff and other relevant parties and individuals involved in the trial conduct are provided with necessary instruction on properly

(iv)

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