Sunday, September 19, 2010

Question & answer By Dr. ARUN BHATT

Post-marketing safety depends on the objective
Thursday, December 03, 2009 08:00 IST
Dr Arun Bhatt

We are doing one clinical trial in that serious adverse event occurred after completion of study period. What we should do?
It would be desirable to report this event to the sponsor. It also should be reported to ethics committee, and regulatory agency after causality and expectedness are assessed. See ICH guidance below.

ICH E2A 3. Post-study events
Although such information is not routinely sought or collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for expedited reporting purposes as though they were study reports. Therefore, a causality assessment and determination of expectedness are needed for a decision on whether or not expedited reporting is required

For bioequivalence study of an anticancer agent, is it necessary to dose all the subjects in one single day?
Rendeep Rajendran
There is no regulatory requirement to dose all the subjects in one single. As anticancer drugs usually cause adverse events, it would be desirable to take small cohorts of patients.

Many of the Institutional Ethics Committee do not clearly mention reporting annual status/progress report during the course of study. What are the steps to be taken for this situation especially when you are looking forward to select this site because PI is good/experienced investigator and site infrastructure complies with the current study requirement?
ICH GCP mandates that IEC should review the project at least once a year. Indian GCP recommends that IEC has the responsibility of continuing review. Schedule Y EC approval recommends that EC letter mention that EC expects to be informed of the progress.

ICH GCP 3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
3.3.3 Conducting initial and continuing review of trials.

Schedule Y
The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information / informed consent and asks to be provided a copy of the final report.

Indian GCP
The Ethics Committees are entrusted not only with the initial view of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the Ethics of the approved programmes till the same are completed.

It is necessary to bring to the notice of investigator / EC about this requirement and to request that their SOP cover this requirement for annual review.

Kindly let me know whether can we use comparator in Post Marketing Surveillance study. What is the necessity to use comparator after regulatory approval to market the product?
The PMS design depends on the objective. If the objective is to assess post-marketing safety of a new drug, comparator is not required. However, if the objective to assess efficacy vis-a-vis other therapy/new therapy on the market and to support marketing claims, a comparator is usually required

Are any foreign reports for the same product (marketed in India) required by DGCI?
Niharika Mathur
Please check the DCGI approval letter. It does not clearly state - local or foreign reports. As a practice, most foreign companies in India send local reports only.

Are local expected events reportable?
Niharika Mathur
As a convention all post-marketing events are considered drug related and are reported to DCGI

Which cases should be included in the PSUR?
Niharika Mathur
All cases - local / foreign - will be in PSUR.

As per Indian GCP sub-investigator & co-investigator are synonymous
Thursday, January 07, 2010 08:00 IST
Dr Arun Bhatt

Our Neurosurgeon wants to participate in a surgical trial sponsored by an international not-for-profit institute. The investigators are recruited through the trial website. Trial objective is primarily to compare early vs. late interventions intra-cerebral hemorrhage. There is no financial involvement in the trial; no agreements, no indemnity and no insurance.

The issues are:
a) Can take place without the approval of a regulatory body in India considering the trial sponsor is based outside the
b) Which regulatory framework should Ethics Committee use to evaluate such studies?
c) Will CTRI registration be required and if so, is it
the investigator's responsibility?
d) Can data emanating from Indian sites (Indian patients) be shared with any regulatory approvals?
e) How about subject protection in case of injury because of delayed surgery?
Dr. Sumeet Roy

Regulatory and ethics issues:
As the study does not involve a new drug or device, it does not come under DCGI purview.
MCI Code of Ethics Regulations recommends the following:

7.22 Research: Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.

Hence the neurosurgeon should follow the ICMR guidelines. These guidelines in ethics committee section cover all types of research and classify it according to the level of risk. The decision re: level of risk is to be made by the EC and not the investigator. Pl also see section on international collaboration and epidemiology. All these point to the need for 1) EC review 2) Informed consent.

CTRI Registration
All interventional clinical trials conducted in India and involving Indian participants need to be registered. An interventional clinical trial is any research study that prospectively assigns people to one or more health-related interventions (e.g., preventive care, drugs, surgical procedures, behavioural treatments, etc.) to evaluate their effects on health-related outcomes. Thus, early and late trials, trials of marketed or non-marketed products, randomized or non-randomized trials - all should be registered.

At present, The CTRI registration is purely voluntary; however, registration is likely to have a lot of advantages both for the registrant as well as the public. Further, prior registration is now a condition of publishing clinical trial data. From 1st July 2005 the International Committee of Medical Journal Editors (ICMJE) have declared that their journals will not publish the results of any clinical trials not included on an authorized register at the trials inception.

Data transfer
As regards data from Indian patients going out, one needs to consider the contribution of this data and the objective of international study. If the study has a large contribution from India, there should be a legal contract with the sponsoring agency re: use of data and potential benefits - authorship, royalty etc.

Subject protection
Providing protection to a subject in case of an injury is responsibility of the investigator and the institute. See ICMR guidelines below:

ICMR guidelines section Compensation For Accidental Injury:
Research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, their dependents are entitled to material compensation.

Obligation of the sponsor to pay: The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research begins, in the a priori agreement to provide compensation for any physical or psychological injury for which participants are entitled or agree to provide insurance coverage for an unforeseen injury whenever possible

Can a homoeopathic doctor, with 5 years of industry experience as a senior CRA, become sub-investigator?
Dr R Yadav

As per Indian GCP Sub-investigator and Co-investigator are synonymous.
Co-investigator: A person legally qualified to be an investigator, to whom the Investigator delegates a part of his responsibilities.

ICH GCP 1.56 Sub-investigator: Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

According to a recent US FDA guidance, during a subject's participation in a trial, the investigator (or designated sub-investigator) should ensure that reasonable medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial participation.

Considering the above, a sub-investigator has to perform critical trial related procedures, make important decisions, and should be able to provide medical care for adverse events. Hence, the sub-investigator should be legally qualified to undertake these responsibilities.
Hence, a homeopathic doctor would not be able to take the role of a sub-investigator.

How does one report a pregnancy occurring during a trial? As an SAE?
Rohit Shetty

In most international trials, a pregnancy occurring during a trial is reported on a 'pregnancy report form'. In India, there is no regulatory guidance on pregnancy reporting. Hence, it needs to be reported as a serious adverse event.

A pregnancy would be reported as an SAE when there's any complication e.g. miscarriage etc, which meets one of the criteria of seriousness or if the baby is born with congenital defects. However, if a protocol defines all pregnancies to be reported as SAE, one has to follow the protocol.

EC approval is mandatory for all trials including herbal medicines
Wednesday, February 03, 2010 08:00 IST
Dr Arun Bhatt

Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may

What is a bridging study? Do we require DCGI approval for such a study?
V. Sridhar
There is no concept of bridging study in Indian regulations. All Indian trials require DCGI approval

As per ICH E 5

A bridging study is defined as a study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region.

One of the criteria for the adverse event to be considered as SAE is hospitalization as per the guidelines. But if during the study, the subject is taken to hospital for some time in emergency unit assistance, expert consultation or short-term observation for management of an AE and the subject is discharged on the same day. In that case should we consider it as SAE or not?
Dr Muneesh Garg
US FDA in response a query has advised the following:
“Common usage of "inpatient hospitalization" generally would include being treated by a physician in a hospital for at least a 24-hour period.”

What is the importance of ‘note-to-file' and when it should be a document?
Dr Prakash Atlam
Please see some of the literature excerpts on 'note-to-file'. A Note-to-file is a way to explain any discrepancy in the conduct of a research study or to clarify a decision made in regards to some aspect of the study.

Note-to-file is helpful if it covers the following:
● Identification of a problem
● Identification of a procedural change for preventing recurrence
● Institution of the procedure

Note-to-file is written by site team in site files and in the company files by concerned CRA. It is not submitted to regulatory authorities. However, they can view it in the files.

If there is a regulatory inspection, the inspector may cite the initial problem. However, a note-to-file describing the change in procedure mitigates the citation and supports the site in responding to the finding. .

It is recommended that a 'note-to-file' does not become a device to allow a research investigator or coordinator to ignore protocol or to accept laxity in conduct of a study.

In a clinical trial, is it mandatory that laboratory investigation reports should be signed by MD (Path)?
Shruti Kulkarni
As per NABL, the qualifications required for authorization depends on the nature of lab test. The person could be MD/Phd/MSc/MBBS.

We have got BE NOC (Export) from DCGI - 60 human volunteers and the innovator product is from USA. If we want to conduct the same study with lesser number of volunteers (i.e. <60, say 24) and the innovator product from Europe (same innovator - mfg location is different), whether we need to obtain amendment approval for the approved NOC or to apply fresh NOC or to send an intimation to DCGI without waiting for the approval. Will this change be considered as major or minor? Balaji K For the change in number of volunteers, there is no need for amendment, as there is no addition in the number of volunteers. For the change in manufacturing site, you will require amendment of the import license. If this information is part of protocol, this will be a logistic change which does not require notification / approval of the protocol amendment. Good Clinical Practices DCGI permission insists that the sponsor should follow Indian GCP guidelines whilst conducting trial in India Thursday, April 01, 2010 08:00 IST Dr Arun Bhatt If there is no difference between these following two guidelines then why are these prepared separately? Vij Chauhan Indian GCP guidelines have been evolved with consideration of WHO, ICH, US FDA and European GCP guidelines as well as the ethical guidelines for biomedical research on human subjects issued by the Indian Council of Medical Research. ICH GCP guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the WHO. Due to this, there are differences between ICH and Indian GCP in glossary, ethics segment, safety reporting, monitor’s responsibilities etc. Also, Indian GCP covers areas not covered by ICH GCP e.g. herbal preparations, vaccines, devices etc. Hence, both guidelines need to be followed if an international trial is being conducted in India. DCGI permission insists that the sponsor should follow Indian GCP guidelines whilst conducting the trial in India. For phase 4 study initiated by pharma co is it necessary to provide study subjects insurance? Is it mandatory to take EC approval from all study centres for phase 4 study initiated by co (non-comparative open label study)? Is it mandatory to take DCGI approval before initiation of phase 4 study? Dr Arindam Dey Phase IV can cover different types of studies. (see ICMR 2006 guideline) You need to assess in which category your study falls. If it is an open label study, it will be like a phase III study. Hence, EC approval and patient insurance will be essential. If the indication is not as per DCGI approved indication, it will be necessary to take DCGI approval. ICMR 2006 guidelines on phase IV The phase IV studies should have valid scientific objectives. After approval of the drug for marketing, phase IV studies or post marketing surveillance is undertaken to obtain additional information about the risks and benefits resulting from long term usage of drug. It is an important aspect of drug trial on the longterm effects of the drugs and the adverse reactions induced by drugs, if any, should be brought to the notice of the Ethics Committee. There is a need to correlate the adverse events reported during phase IV trials with the toxicity data generated in animals, to draw markers for future warnings of potential adverse events likely to occur with other drugs. These trials may not be necessary for approval of new drug for marketing but may be required by the Licensing Authority for optimizing its use. These studies also include those on specific pharmacologic effect, drug-drug interaction(s), dose-response studies, trials designed to support use under approved indication(s) e.g. mortality/morbidity studies, clinical trials in a patient population not adequately studied in the pre-marketing phase, e.g., children; and epidemiological studies etc. Bioequivalence and bioavailabilty study also falls under this category. In addition there are phase IV studies that are designed to evaluate the marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. The drug is used for the labeled indication in these studies. Therefore Licensing Authority permission is not needed. However, EC permission is needed. A third type of post-marketing study involves evaluation of the drug for a new indication of a marketed drug, e.g. studies with letrazole. Here, DCGI permission and EC approval are needed which really makes the trial a phase III study. A homoeopathy doc holds a patent for homoeopathic medicine. He wants to run trial with same medicine at his own hospital as principal investigator and will be a self funded trial. No other centre will be involved in trial beside his own hospital. Central lab will be used for blood sample analysis; and an independent monitor will be monitoring this trial. I have following questions: Will it be OK that patent holder investigator can do the trial? Will there be any chance of bias in conduct of trial? How to prevent bias in such trials? Will data generated by this trial be accepted by GCP? Do we require DCGI approval for homoeopathy medicine? Geeta Talele A patent holder can conduct the trial. However, his own interest in the product can bias him to give positive results. Hence, he should organize the trial in way that his own interest in the product does not influence the documentation and measurement of efficacy / safety end points. The only way to avoid bias is by letting another investigator conduct the trial. The data will be acceptable if the trial conforms to GCP guidelines. This means that all aspects of the trials - design, conduct, monitoring, recording, analysis, reporting - meet GCP standards, As homoeopathy research comes under Dept of Ayush. You will need to check with them re: Ayush procedures for approval. DCGI approval is not required. Can we conduct a bioavailability study (pharmacokinetics) for the drug which is not available/approved in India in healthy volunteers (10-12). The objective of the study would be just to understand or analyze the pharmacokinetic behaviour in human subjects. In such scenario only ethics committee approval is sufficient or DCGI approval is required? Rudolph Almeida If it is not available/approved in India, you will need a test import license from DCGI office to import the drug for pharmacokinetic study. Hence, DCGI approval of the protocol will be necessary. ICH GCP requires EC members to be independent of investigator and sponsor to avoid conflicts of interest Thursday, June 03, 2010 08:00 IST Dr Arun Bhatt Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject? Vidya If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered: ● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable. ● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study). ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid conflicts of interest. Is it mandatory to have a qualified pharmacist for pharmacy activities like for dispensing? Chetan Shingala I assume your question pertains to site. As per ICH-GCP, the site can have a pharmacist or another individual for IP related responsibilities. See below. 4.6 Investigational product(s) 4.6.2Where allowed/ required, the investigator/ institution may/should assign some or all of the investigator's/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution. 4.6.3 4.6.3The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor. In an investigator initiated trial the interventions are: one group assigned an approved drug (for same indication) in India and the control group with life style modification. The question is a) Is this a randomized controlled trial or an observational study or other designs? b) What phase of trial is this? c) Do we need DCGI approval? J. Vijayakumar ● This is clinical trial as you are comparing two interventions. As the comparison is between a drug and a non-drug measure, it is difficult to randomize and blind the study. It will be desirable to have blinded observers and objective endpoints, if the trial results are to be considered valid. ● It’s a Phase IV as the drug is being used for approved indication. ● DCGI approval is not needed. See ICMR 2006 guidelines excerpt below:There are Phase IV studies that are designed to evaluate the marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. The drug is used for the labeled indication in these studies. Therefore Licensing Authority permission is not needed. However, EC permission is needed. If one patient has reported the same adverse event throughout the study, are we supposed to count it as one adverse event or are we supposed to count it visit wise? For e.g. if the patient has reported nausea continuously from day 0 to day 14 and if there are 4 visits during day 0 to day 14, then are we supposed to count nausea as one single adverse event or it will be counted as different adverse events? Shruti Kulkarni It depends on whether the first event subsided or is continuing. If the first event has subsided, and if the subject complaints of the same event again, it will be considered a new event. If the event has not subsided, only one event will be reported as continuing. Ethics Committee has their own SOP and their own format for approval. Is it necessary to have approval in Schedule Y format? Dr. Hemant Zaveri The EC can have its own format. But the approval format should cover all requirements of Schedule Y. In India, there is no separate guidance on pregnancy reporting Thursday, August 05, 2010 08:00 IST Dr Arun Bhatt How will we conclude that the subject is illiterate? Dr Prakash Atlam The guidelines don’t use the term illiterate. Their focus is subject’s ability to read and/or write. Schedule Y treats anyone who is unable to read or write in the same way. See the excerpt below. If the subject or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form. While designing a protocol we found that there are high likely chances of worsening of some of the symptoms. Do we have to wait for these to happen and report it as SAE or in case we define them in the protocol upfront then can we prevent from expediting reporting it as SAE? Om Please see suggested guidance from ICH. Exemption from reporting such events would require prior agreement with regulatory authorities. ICH E3 12.2.2 Display of Adverse Events: All adverse events occurring after initiation of study treatments (including events likely to be related to the underlying disease or likely to represent concomitant illness, unless there is a prior agreement with the regulatory authority to consider specified events as disease related) should be displayed in summary tables (section 14.3.1). The tables should include changes in vital signs and any laboratory changes that were considered serious adverse events or other significant adverse events. In most cases, it will also be useful to identify in such tables "treatment emergent signs and symptoms" (TESS; those not seen at baseline and those that worsened even if present at baseline). ICH E9 In situations when there is a substantial background noise of signs and symptoms. (e.g. in psychiatric trials) one should consider ways of accounting for this in the estimation of risk for different adverse events. One such method is to make use of the “treatment emergent' (see Glossary) concept in which adverse events are recorded only >if they emerge or worsen relative to pretreatment baseline.

Other methods to reduce the effect of the background noise may also be appropriate such as ignoring adverse events of mild severity or requiring that an event should have been observed at repeated visits to qualify for inclusion in the numerator. Such methods should be explained and justified in the protocol.

In a two period cross-over BA/BE study, if any AE occurs on the day of dosing of period-2 but before dosing of period-2 e.g. fever. Then obviously the subject will not be dosed for period-2. In this case, in which AE form we should record the AE i.e. AE form for period-1 or period-2. Because all the information like relationship to the study medication, last dosing date & time, treatment code and time elapsed since last dosing etc will be considered with respect to dosing time and date of period-1 only. Please suggest in which AE form we should record the pre-dose AEs of period-2 i.e. AE form for period-1 or Period-2.
Dr Muneesh Garg
Going by the logic and practice of clinical trials, as the subject was screened and was waiting to be enrolled for period 2, the AE would be recorded in period-2 form. On the other hand, in clinical trials adverse events are followed up-to 30 days after the last visit/completion of protocol. By this logic, one can consider the AE as occurring in post-period 1 drug follow-up.

As long as the details are captured in the form, it would not matter in which form you capture period 1 or 2. In clinical trials, we use only 1 AE page. The details filled on the page are adequate to relate the drug to the causality assessment.

Let me know whether pregnancy detected after completion of one period of a BE study is an SAE?
Nanda Kumari
Pregnancy is special medically significant condition SAE requiring reporting.

Internationally, pregnancy is reported separately. In India, there is no separate guidance on pregnancy reporting. Hence, it will be reported as an SAE.

Is there any difference between Independent EC and Institutional EC?
Dr Sreevatsa
The only difference is their location. Institutional ECs function in Institutions. (GCP Definition: Institution - any public or private medical facility where a clinical study is conducted). The ECs which are not attached to any institution are considered private ECs abroad and independent ECs in India. However, the major difference is in their scope of authority. If there is a trial in an institution, the investigator has to seek approval of the institutional EC.u

Clinical trial processes for medical devices are similar to that of drugs
Wednesday, September 01, 2010 08:00 IST

Can you advice how clinical trials can be done using indigenous medical devices in India?
J. Vijayakumar
As of today, most medical devices (a comprehensive & updated list available from the CDSCO website) are considered as drugs for the purpose of clinical trial and come under the purview of the D&C Act. The clinical trial/evaluation process for these devices are similar to that of clinical trial process for drugs in India.
Recently, CDSCO has also released a draft guideline for comments:
● Requirements for conducting clinical trial(s) of medical devices in India
● Guidance document on common submission format for registration of medical devices in India
These guidelines suggest the approach for application/permission for clinical trials. The overall approach is similar to drug trials with specific differences as per nature/type/class of device.
Another draft guideline, the Schedule MIII is available from CDSCO website which outlines the clinical trial process and requirements for devices. Some specific points are as follow; however, this guideline is only a draft and is awaiting finalization.
● Trial should aim at verifying whether the device conforms to 'essential requirements' for medical devices as stipulated in the guideline
● Trial should be compliant to ISO 14155 standard, in addition to Declaration of Helsinki

What are the concerns if we want to set up a Central EC within same group of hosps? What are the issues with having 2 ECs - Central and Local at individual hospitals?
Dr. Sanjay Basumatary
Although the idea looks sound in principle, some concerns remain. These are:
Overall time frame for approval from 2 ECs.
If there is a dispute, whose decision will be final.
Additional burden of the investigator in complying to the documentation/queries of 2 committees
Central EC oversight at trials at different hospitals
Impact duplication of reporting progress report/SAE etc
Perception of sponsors re: above issues and impact on selection of the hospital as a site.

Is there any special requirement for sending the literature cases (articles to accompany the case report) to the DCGI? Moreover, is there any requirement laid down by the Indian regulations to periodically search the relevant literature databases (i.e. Medline) for drugs marketed in India?
Niharika Mathur
There is no specific guidance on this issue. However, the Schedule Y PSUR guidance covers "all the relevant new information from appropriate sources". Hence, it would be important to report literature cases as part of PSUR. See Schedule Y section below: Post Marketing Surveillance - Subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in order to report all the relevant new information from appropriate sources.

How should the consumer reports be treated for reporting purposes?
Niharika Mathur
If these are safety reports, depending on seriousness, they would be reported either as post-marketing spontaneous reports or as part of PSUR.

For clinical trial events, is any cross reporting required by DCGI for the cases occurring in the same clinical trial in the other centres of the trial (outside India)?
Niharika Mathur
There is no clarity on this issue. Schedule Y and Indian GCP use the words "any" or "all". Hence, most sponsors/CROs report all SAE/ SUSARs from India and other countries to DCGI and participating sites ECS. See Schedule Y section below:

(iv) Any unexpected serious adverse event (SAE) (as defined in GCP guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the sponsor to the licensing authority and to the other investigator(s) participating in the study (see Appendix XI).

Indian GCP 3.1.11. Adverse Drug Reaction Reporting:

The sponsor should provide ADR / AE reporting forms to the investigator(s) / institution(s). The sponsor should expedite the reporting to all concerned (including the EC and the regulatory authorities) of all serious and/or unexpected adverse drug reactions.

Also, I have heard that the only way to report to the DCGI is to visit their office in person and get the case report (clinical/post marketing) stamped for acknowledgement? Does the same hold true for PSUR/ annual reports too?
All safety information - SAE / PSUR, has to be submitted in hard copy form personally. This will facilitate getting the acknowledgement on the safety information. There is new annexure form for all notifications to DCGI


  1. Has the process of importing and exporting biological samples (Clinical trial blood samples for analysis) changed recently?
    What is the current process, documentation and timelines please?
    Jaydev Tiwari

  2. HI , IMPORTANT AND URGENT,Q: IS THERE ANY GUIDLINES AND/OR reference of the same in Schedule Y and/ or any other applicable regulatory guideline or IS DCGI ISSURE ANY letter that DCGI approval is not required for NON-INTERVATIONAL OBSERVATION STUDY.

  3. what is the difference between registries and clinical trials? when are the registries conducted? what are the regulatory requirements for the same? also do we need to take permission from DCGI or do we have to just notify the DCGI??

  4. one among recent notifications from CDSCO mentions that " Drugs considered generics and similar biologicals in other countries like USA that have been marketed in these countries for more than 4 years and have a satisfactory report would be approved for marketing in India after abbreviated trials. "

    what does this abbreviated trial exactly mean?

    Dr. Tanvi Shah


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About Me

Hyderabad, Andhra, India
working as a clinical Research coordinator at yashoda Hospital,Somajiguda,Hyderabad