Drug Trial Ethics Committee (DTEC)
The Drug Trial Ethics Committee (DTEC) of Dayanand Medical College & Hospital is CDSCO registered and NABH accredited Ethics Committee. The DTEC reviews all the study projects including sponsors clinical and non-clinical trials, PI initiated studies and ICMR projects.
Registered with
- CDSCO (Central Drugs Standard Control Organization) No. – ECR/101/Inst/PB/2013/RR-24
- DHR (Department of Health Research) – No. EC/New/Inst/2021/2297
- HHS (U S Department of Health and Human Services): IORG No. IORG0010063
- NABH Accredited: EC-CT-2018-0052
The list of DTEC SOPs is as below:
| Sr. No. | Name of SOP |
|---|---|
| 1. | DTEC Standard Operating Procedure |
| 2. | SOP to make or amend the SOP |
| 3. | SOP for issue of SOP documents |
| 4. | SOP for Serious Adverse Events (SAEs) |
| 5. | SOP for Maintenance of current study files, administrative records, archival of closed files and retrieval of documents and file disposal |
| 6. | SOP for attrition of PI, CO-I and study staff |
| 7. | SOP for monitoring of Ethics Committee by regulatory authorities |
List of DTEC Members:
| Sr. No. | Name | Designation in DTEC | Affiliation with Institute |
|---|---|---|---|
| 1 | Mr. Sunil Gupta | Chairman | No |
| 2 | Dr. Shalini Arora | Member Secretary and Basic Medical Scientist | Yes |
| 3 | Dr. Sandeep Kaushal | Member and Basic Medical Scientist | Yes |
| 4 | Mrs. Sangita Sareen | Member and Layperson | No |
| 5 | Mrs. Jagdeep Singal | Member and Social Worker | No |
| 6 | Mrs. Avantika Gupta | Member and Layperson | No |
| 7 | Dr. Rubina Mahajan | Member and Clinician | Yes |
| 8 | Dr. Jaspriya Sandhu | Member and Clinician | Yes |
| 9 | Mr. S S Saini | Member and Legal Expert | Yes |
| 10 | Mr. G L Bassi | Member and Social Worker | No |
| 11 | Mrs. Gauri Chhabra | Member and Social Worker | Yes |
| 12 | Mr. Bharatbir Singh Sobti | Member and Legal Expert | No |
Contact details for any kind of information/query
Mr. Deepak Kumar
Coordinator,
Drug Trial Ethics Committee (DTEC),
Institutional Ethics Committee (IEC),
DMC & Hospital, Ludhiana-141001
Email Id: dtec@dmch.edu, ethics.dmch@gmail.com
Mobile: 98765 11974
Institutional Ethics Committee (IEC)
The Institutional Ethics Committee (IEC) of Dayanand Medical College & Hospital is DHR registered Ethics Committee. This IEC reviews all research projects/proposals in human subjects and/or patients (including medical education projects, human studies, audits, registries, retrospective studies excluding case reports and project proposals submitted to external funding agencies (e.g. Indian Council of Medical Research, etc.). The scope includes postgraduate programs (MD, MS, DM, MCh, M.Sc Nursing, B.Sc/M.Sc Nursing), PhD theses, and MBBS student projects from DMC & Hospital, as well as from the following three institutes with which an MoU has been signed:
- IIT, Ropar
- Punjab Agriculture University (PAU), Ludhiana
- Guru Angad Dev Veterinary And Animal Sciences University (GADVASU), Ludhiana
Registration with DHR (Department of Health Research)
No. EC/NEW/INST/2022/PB/0160, dated: 30/Aug/2022
IEC SOP: The current SOP ver. 3.2 is being used.
Document checklist for Project Submission
| Sr. No. | Descriptions | Status |
|---|---|---|
| 1 | Covering / Forwarding Letter | |
| 2 | Approval Letter from MAC | |
| 3 | All Sections (section 1-6) of the DMC&H IEC Project Submission form version 2 (can be downloaded here ) | |
| 4 | Subject Information Sheet | |
| a) English | ||
| b) Hindi | ||
| c) Punjabi | ||
| 5 | Informed Consent Form | |
| a) English | ||
| b) Hindi | ||
| c) Punjabi | ||
| 6 | Planned Budget | |
| 7 | All Performa | |
| a) Questionnaires | ||
| b) Assessment Forms | ||
| c) Scales | ||
| d) Interviews | ||
| e) Surveys | ||
| f) Diaries | ||
| 8 | Current Curriculum Vitae (CV) of PI signed on every page |
The current Composition of IEC is as follows:
| Sr. No. | Name | Designation in IEC |
|---|---|---|
| 1. | Mrs. Avantika Gupta | Chairperson, External Member |
| 2. | Dr. Rajesh Mahajan | Clinician, Member Secretary |
| 3. | Dr. Sandeep Kaushal | Basic Medical Scientist, Internal Member |
| 4. | Adv. Rajat Malhotra | Legal Expert, External Member |
| 5. | Mr. G L Bassi | Social Scientist, External Member |
| 6. | Dr. Sanjeev K. Uppal | Clinician, External Member |
| 7. | Dr. Birinder S. Paul | Clinician, Internal Member |
| 8. | Dr. Ramit Mahajan | Clinician, Internal Member |
| 9. | Mr. Jagdeep Singal | Social Scientist, External Member |
| 10. | Dr. Ashvind Bawa | Clinician, Internal Member |
| 11. | Dr. Suvir Singh | Clinician, Internal Member |
| 12. | Mrs. Sangeeta Sareen | Layperson, External Member |
| 13. | Mr. Sameer Ralhan | Layperson, External Member |
| 14. | Dr. Anu Sharma | Basic Medical Scientist, Internal Member |
Contact details for any kind of information/query
Mr. Deepak Kumar
Coordinator,
Drug Trial Ethics Committee (DTEC),
Institutional Ethics Committee (IEC),
DMC & Hospital, Ludhiana-141001
Email Id: dtec@dmch.edu, ethics.dmch@gmail.com
Mobile: 98765 11974
Dayanand Medical College & Hospital
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