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‘An impartial witness is required only if the subject is illiterate’
What are the guidelines for conducting clinical trials
of cosmetic products?
S Ranganathan
There are no special/separate guidelines for clinical trials of cosmetic products.
General principles for any drug trial are applicable.
I have the following queries on amended Schedule Y:
a) Which permission is required to be taken first by the sponsors: the Ethics
Committee (EC) or regulatory authorities?
b) In the list of references to be attached with the clinical trial report,
two of the references are patient data listings. What exactly does this mean?
Case Report Forms (CRFs) of cases involving death and life threatening adverse
event cases. Does this mean original CRFs?
c) In case of a Serious Adverse Event (SAE), till what point can an investigator
and a sponsor follow up?
Deepti Dua
a) The sponsors can apply for permission from EC and regulatory authorities
concurrently.
b) ICH E 3 guidelines on preparing report cover the details.
c) SAE is followed till resolution or till there is a steady state eg. stable
values of abnormal liver function or as specified in the protocol eg. one month
after completion of treatment and follow-up.
Can a sponsor (for single centre trials) consult an independent
EC to approve the study when a local EC is present?
Shabana N
It is the responsibility of an EC to safeguard the rights, safety and well-being
of all trial subjects. The Institutional Ethics Committee (IEC) also has to
conduct a continuing review of the approved trial and assess reports of AEs.
In case of any major issues, for example death of a subject, there could be
medico-legal issues for the sponsor/investigator/institute. In such a situation,
the regulatory authorities approach the IEC to investigate the matter.
If the trial is not approved by an IEC and if there is an inquiry into the conduct
of clinical trial, the sponsor and investigator will find it difficult to satisfy
the enquiry committee. Besides, during regulatory inspection, the inspectors
usually wish to meet the EC and audit their processes. In view of all these
considerations, the best option for ethical, legal and practical reasons is
to seek approval for the IEC.
I am conducting a multi-centric trial and one of the criteria
for inclusion is 18-70 years old male/female. But one investigator recruited
patients aged 15 years. Is this a protocol deviation or GCP violation? If we
become aware of such a deviation during the trial, what is the course of action?
Sweety Sutaria
As per ICH GCP 4.5.1 the investigator should conduct the trial in compliance
with the protocol. Hence, this is a GCP violation. If you become aware of an
inclusion of any patient who is 15 years of age at any stage during the trial,
the patient should be withdrawn from the trial. The reason for withdrawal should
be documented in the CRF and reported in the final report for regulatory submission.
a) In a situation where the symptoms of the disease reappear during the study
period after not being present for sometime before during the study; what do
we call these-adverse event or exacerbation of the disease. Is it necessary
to mention its reappearance?
b) Should the contact information of the site and investigator be in vernacular
language if the Informed Consent Document is given in vernacular language or
can it be in English?
Dr Manisha Maganji
a) It would depend on the judgment of the investigator. If the symptoms appear
to be an exacerbation of underlying disease, it has to be recorded as per the
follow-up visit re-cord requirements. However, if the investigator feels that
these symptoms cannot be explained as an exacerbation and possibly have a link
with the investigational drug, they have to be recorded as AEs.
b) The objective of the contact information is to facilitate the patient in
case of any issues about the trial. Hence, the contact information should be
in vernacular language.
a) Is it necessary to have an impartial witness sign the Informed Consent form
in BA/BE trials?
b) Can the witness be another study subject in the same BA/BE trial?
Kavitha Muniraj
a) No. An impartial witness is required only if the subject is illiterate and
his legal representative is illiterate.
b) As per ICH-GCP definition an impartial witness is a person, who is independent
of the trial, who cannot be unfairly influenced by people involved with the
trial.
As the other study subject is involved in the study, he can be influenced by
the study team. Hence, he can not become an impartial witness.
Dr Arun D Bhatt, well-known clinical pharmacologist from
Mumbai, and currently president, ClinInvent Research India Pvt Ltd, answers
your questions on Good Clinical Practices. Please send in your questions at:
arunbhatt@clininvent.com
All queries should ideally reach him by the 15th of each month
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