GSER-IEC is ISO 9001:2015 qualified quality management system and registered with CDSCO, U.S. Department of Health and Human Services and accredited with NABH.
Good Society for Ethical Research – Independent Ethics Committee (GSER-IEC) is an independent body constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of human subjects participate in clinical study including BA/BE studies and provide assurance of their protection, by among other things, review and approve / providing favourable opinion on, the study protocol, the suitability of the investigator(s), facilities, and the methods & material to be used for documenting and obtaining informed consent from the trial subjects.
GSER-IEC constituted under rule 7 of New Drugs and Clinical Trial Rules 2019 and registered with and Drugs Controller General of India – Central Drugs Standard Control Organisation (CDSCO) (Reg. No.- ECR/69/Indt/DL/2013). Our IEC is also registered with the U.S. Department of Health and Human Services (DHHS # IRB00005032), accredited with National Accreditation Board for Hospitals & Healthcare Providers (NABH)-(Certificate No – EC-CT-2019-0115) and having ISO 9001:2015 quality management system.
The composition is in compliance with ICH-GCP guidelines as well as New Drugs and Clinical trial Rules 2019 which includes
| Sr.No | Members of EC | Eligibility |
|---|---|---|
| 1 | Chairperson/ Vice Chairperson (optional) Non-affiliated | A well-respected person from any background with prior experience of having served/serving in an EC. |
| 2 | Member Secretary/ Alternate Member Secretary (optional) Affiliated | Should be a staff member of the institution Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills. Should be able to devote adequate time to this activity which should be protected by the institution. |
| 3 | Basic Medical Scientist(s) Affiliated/ non-affiliated | Non-medical or medical person with qualifications in basic medical sciences In case of EC reviewing clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist |
| 4 | Clinician(s) Affiliated/non-affiliated | Should be individual/s with recognized medical qualification, expertise and training |
| 5 | Legal expert/s Affiliated/non-affiliated | Should have a basic degree in Law from a recognized university, with experience Desirable: Training in medical law. |
| 6 | Social scientist/ philosopher/ethicist/theologian Affiliated/ non-affiliated | Should be an individual with social/behavioural science/ philosophy/religious qualification and training and/or expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities |
| 7 | Lay person(s) Non-affiliated | Lay person(s) Non-affiliated Literate person who has not pursued a medical science/health related career in the last 5 years May be a representative of the community and aware of the local language, cultural and moral values of the community Desirable: involved in social and community welfare activities |
GSER-IEC is ISO 9001:2015 qualified quality management system and registered with CDSCO, U.S. Department of Health and Human Services and accredited with NABH.
The research study protocols are sound in design, scientifically justified, and statistically valid.
The research studies are conducted according to the New Drugs and Clinical Trials Rules 2019, Indian Council of Medical Research and Good Clinical Practice guidelines.
The research study does not compromise rights, safety and benefits of the patients/volunteers/study participants.
The research studies are conducted under the supervision of trained medical/bio-medical persons with required expertise.
The research studies include only those patients or participant who have given voluntary and informed consent without any inducement or coercion.
Review and accord approval to a clinical trial, bioavailability or bioequivalence study protocol and other related documents and oversee the conduct of clinical trial to safeguard the rights, safety and wellbeing of trial subjects in accordance with NDCT Rules -2019, Good Clinical Practices Guidelines and other applicable regulations;
Make at appropriate intervals, an ongoing review of the clinical trials for which it has accorded approval and such review may be based on periodic study progress reports furnished by the investigators or monitoring and internal audit reports furnished by the sponsor or by visiting the study sites;
Indicate the reasons that weighed with it while rejecting or asking for a change or notification in the protocol in writing.
In case of any serious adverse event occurs to a trial subject or to study subject during clinical trial or bioavailability or bioequivalence study, the GSER-IEC shall analyse the relevant documents pertaining to such event and forward our report to the Central Licencing Authority and comply with the provisions of Chapter VI of NDCT Rules-2019
In any stage of a clinical trial, it comes to a conclusion that the trial is likely to compromise the right, safety or wellbeing of the trial subject, GSER-IEC may order discontinuation or suspension of the clinical trial and the same shall be intimated to Investigator conducting clinical trial and the Central Licencing Authority by GSER-IEC
GSER –IEC will allow any officer authorised by the Central Licencing Authority to enter, with or without prior notice, to inspect the premises, any record, or any documents related to clinical trial, furnish information to any query raised by such authorised person, in relation to the conduct of clinical trial and to verify compliance with the requirements of these rules, Good Clinical Practices Guidelines and other applicable regulations for safeguarding the rights, safety and well-being of trial subjects;
GSER-IEC shell comply with the requirements or conditions in addition to the requirements specified under the Act and these rules as may be specified by the Central Licencing Authority with the approval of the Central Government, to safeguard the rights of clinical trial subject or bioavailability or bioequivalence study subject.
The Principal Investigator (PI) or PI representative can submit research proposal to the GSER office for ethical review and approval under any of the five sections mentioned below:
All proposals should be submitted in the prescribed application form, the details of which are as per GSER-IEC submission check list (available in download section). All relevant documents should be enclosed with letter to Chairman/ Member Secretary
Total of 15 hard copies along with one soft copy of study documents will be submitted in case of off line submission, if investigator opt online submission only one hard copy will submit to GSER-IEC office along with GSER-IEC submission check list.
Mode of submission
Online submission (Through https://www.eiecglobal.com) after registration Offline submission – Download GSER-IEC check list from download section and submit EC dossier to GSER-IEC office.
Meeting frequency
The meeting of the GSER-IEC should be scheduled on every 10th, 20th and 30th day of month (±2 days), if have any protocol/s for review and additional meetings may be held in case of any emergency for e.g. due to SAE reporting etc. Study proposals will be sent to members at least 10±3days in advance. Decisions will be taken by consensus after discussions, and whenever needed voting will be done.
GSER has been established by dedicated, experienced clinical research and quality professionals. We believe in working proactively with our customer to bring changes to develop an Ethical mindset. We have a standardized EC review process from submission approval and till study completion through online submission. We have well defined SOP driven process has been put in place for identification and analysis of study updates, AE & SAE reports, Protocol deviation/ violation and GCP non-compliance which in turn would help organizations that approach us for review and approval of their clinical studies.
We believe in working proactively with our customer to bring changes to develop an Ethical mindset on the followings.
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We offers established by dedicated, experienced clinical research and quality professionals
GSER Ethics Committee is an independent body constituted of medical professionals and non-medical members, who are responsible to ensure the protection of the rights, safety and wellbeing of research participate(s) in clinical research.
Team GSER provide consultancy on management of clinical research projects, sample size calculations and Statistical analysis, regulatory services and accreditations by National Accreditation Board for Hospitals and Healthcare Providers (NABH).
Team GSER is actively involved in taking various initiatives towards education and training for clinical research professionals. Our training workshops are designed according to latest guidelines and updates and addressing all major requirements set aside by industry experts.
With a wide range of skills and experience, all EC members share the same goal: For ethical review of clinical research protocols in a timely manner to our clients and safeguard the rights of study participants.
Dr. Vaidehi Garg is ICMR Research Associate working at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi. Her research forte includes development of nanotechnology based ocular drug delivery systems.
She did her PhD in Pharmaceutics in the year 2017 with Research fellowship from Indian Council of Medical Research, India. Dr. Garg provides consultancy to various companies in the field of clinical research and formulation development. She had published in high impact and reputed journals and involved in organizing various workshops/symposium.
Dr. Kanchan Kohli, M.Pharm, Ph.D (Pharmaceutics) is presently working as an Professor, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India with an overall 35 years of experience.
She has more than 150 research and review articles to her credit in various national and international peer reviewed journals, 1 US Patent and 10 Indian patents. She received honor like FIP Congress Travel Grant of 2500 Euros by the Honorable Jury of 69th International Congress of FIP (International Pharmaceutical Federation), which was held at Istanbul, (Turkey), 2009.