The Sourcebook for Clinical Research by Natasha Martien & Jeff Nelligan

Author:Natasha Martien & Jeff Nelligan
Language: eng
Format: epub
ISBN: 9780128162439
Publisher: Elsevier Science
Published: 2018-07-31T16:00:00+00:00

ICH GCP has the following to say regarding trial management:

5.5.1 The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.

In the Introduction to Essential Elements…

8.1 …Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor, and monitor.

In the Introduction to the Investigator’s Brochure (IB)…

7.1 …The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial.

In the Monitoring Report Addendum…

5.18.6(e) …Reports of on-site and/or centralized monitoring should be provided to the sponsor (including appropriate management and staff responsible for trial and site oversight)

In the Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)…

5.13.2 The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions (e.g., protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties (e.g., monitors, investigators, pharmacists, storage managers) of these determinations.

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