What should be the basic qualification (eligibility) of a lay person?
Soma

The definition of lay person is - a person who does not have specialized or professional knowledge of a subject - a person who is a non expert in a given field of knowledge
Hence, this is a person who does not have qualifications of an expert e.g. lawyer, doctor, scientist, chartered accountant etc.

Could you kindly let me know from where I can obtain a copy of Indian FDA Guidelines for handling, storage & distribution of clinical trial material?
Gidy Asrani
Indian GCP covers general guidance in certain sections (see below). In practice, we follow standard GMP guidelines for clinical trial materials for handling, storage and distribution.
Indian GCP 2.3.1.6. Handling of the product(s)
? Measures to be implemented to ensure the safe handling and storage of the pharmaceutical products.
? System to be followed for labelling of the product(s) (code numbering etc.)
? The label should necessarily contain the following information: the words - “For clinical studies only”, the name or a code number of the study, name and contact numbers of the investigator, name of the institution, subject’s identification code.

3.1.9. Supply, storage and handling of pharmaceutical products
The sponsor is responsible for supplying the investigational product’s, including comparator(s) and Placebo if applicable. The products should be manufactured in accordance with the principles of GMPs and they should be suitably packaged in the manner that will protect the product from deterioration and safeguard blinding procedures (if applicable) and should be affixed with appropriate investigational labelling.

The sponsor should determine the investigational product’s acceptable storage conditions, reconstitution procedures and devices for product infusions if any, and communicate them in writing to all involved parties, besides stating them on the Product labels where ever possible.

In case any significant formulation changes are made in the investigational product during the course of the Study - the results of any additional studies of the new formulation (e.g. stability, bioavailability, dissolution rate) should be provided to the involved parties to enable them to determine their effects on the pharmacokinetic profile of the Product prior to the use in the Study.

The sponsor should not supply an investigator / institution with the product until the sponsor obtains all required documentation (e.g. approval / favourable opinion from Ethics Committee and Regulatory Authorities).

The sponsor should document procedures and lay down responsibilities for
? adequate and safe receipt, handling, storage, dispensing of the product
? retrieval of unused product from the subjects and
? return of unused product to the Sponsor (or its alternative disposal procedure).

Sponsor should maintain records for retrieval of product (e.g. retrieval after study completion, expired product retrieval etc.).

Sponsor should also maintain records of the quantities of investigational product with proper batch numbers. The sponsor should ensure that the Investigator is able to establish a system within his / her institution for proper management of the products as per the procedures.

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.

Can site initiation be done telephonically?
Bhaskar
Indian and ICH GCP under essential document require Trial initiation monitoring report - To document that trial procedures were reviewed with the investigator and the investigator’s trial staff

The site initiation visit covers several critical aspects of the study, as follows:
? Protocol
? Drug accountability
? AE reporting
? CRF filling
? Monitoring plan
? Regulatory requirements
? Other study specific items – progress report
? Essential documents for investigator study file

This visit is vital for training of the investigator and site staff. Hence, this cannot be done telephonically.

Can LAR be considered an impartial witness?
Bhaskar

See Schedule Y
Prior to the Subject’s participation in the Study the written Informed Consent form should be signed and personally dated by
? (i) The Subject or (ii) if the Subject is incapable of giving an > Informed Consent for example children, unconscious or suffering from severe mental illness or disability, by the Subject’s legal representative or guardian or
? (iii) if the Subject and his legal representative or guardian is unable to read / write, An impartial witness who should be present during the entire informed consent discussion

LAR signs in place of subject, when the subject is unable / incompetent to give consent e.g. minors, patients with severe dementia. A subject who cannot read and/or write is not considered incapable unless he is a minor, unconscious or suffering from severe mental illness or disability.

Ideally, the site should involve a third party as impartial witness. However. most sites tend to use their own personnel as impartial witness, which is incorrect. LAR is not involved in the study and is not a site person. Hence, he/she can be considered impartial witness.


Dr Arun Bhatt is currently,
president, ClinInvent,
Research Pvt Ltd, Mumbai.
Readers can send
their queries at:
arunbhatt@clininvent.com