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FDA investigator usually do not review CTA during inspection

Dr Arun Bhatt
Wednesday, February 28, 2018, 08:00 Hrs  [IST]

What is the regulation/guidance for retention of phase I clinical trial investigational product in India?
Vishal Nakrani


Please consider the following and take appropriate decision:

ICH GCP 5.14.5
The sponsor should: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.

Indian GCP 3.1.9
The Sponsor should maintain sufficient samples from each batch and keep the record of their analyses and characteristics for reference, so that if necessary an independent laboratory may be able to recheck the same.
Drugs and Cosmetics Rules of India recommend:
[(l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;]
As per Indian BE guidelines, the samples must be retained for 3 years after the conduct of the study or 1 year after expiry of the drug, whichever is earlier.

Does US FDA data of clinical trials conducted outside USA?
Dr Ashok Nadkarni  

As per US FDA guidance on acceptance of foreign clinical studies not conducted under an IND, when sponsor conducts a clinical study under an IND outside USA, all FDA IND requirements must be met unless waived.
When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with the requirements in 21 CFR 312.120 in order to use the study as support for an IND or application for marketing approval. Under 21 CFR 312.120, FDA will accept a well-designed, well-conducted, non-IND foreign study as support for an IND or application for marketing approval if the study was conducted in accordance with GCP and if FDA is able to validate the data from the study through an onsite inspection, if necessary.
If the study is conducted outside the United States, the conduct of the study will need to comply with the laws of the country where the study takes place. If the study is to be conducted under an IND, then compliance with FDA's regulations would also be required. Where there are differences between the local laws and regulations and FDA's regulations, the sponsor may need to request a waiver under the IND. If the study is not conducted under an IND but may be submitted to FDA in support of a research or marketing application, then compliance with the requirements in 21 CFR 312.120 would be required.

Do FDA inspectors review Clinical Trial Agreements (CTA) and Confidential Disclosure Agreement (CDA) during investigator site inspection?
Shruti Gopalakrishnan

FDA investigators usually do not review CTA or CDA during an inspection. However, FDA investigator will expect to see investigator agreements and signed 1572 forms.
Please see the links below to FDA’s guidance documents for CI inspections.

Do we have to issue QA controlled copies of protocol, ICF to all investigator sites involved in study? This is not possible as there are many sites for a clinical phase trial.
Neelu Singh

There is no regulatory requirement or industry practice of distributing QA controlled copies of protocol/ICF to sites.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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