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Protocol Guidelines
Any Research protocol/Research study proposal** in which MCC patient data is utilized or MCC is involved as a site must be presented to Institutional Review Board (IRB)-MCC for Scientific (Scientific Review Committee) & Ethical (Institutional Ethics Committee) reviews . The study proposal must have the following main Items:
RESEARCH STUDY PROTOCOL- VERSION 1.0
1. TITLE OF THE STUDY (Possibly Small & Self-Explanatory)
2. NAMES OF PI/CO-PIs (to be mentioned clearly along with Phone. No.s & e-mail IDs)
3. INTRODUCTION
4. LITERATURE REVIEW
5. MAJOR AIMS & OBJECTIVES OF THE STUDY
6. METHODOLOGY USED (Must Contain the Inclusion , Exclusion Criterions, Sample Size, Data Collection Procedures, Major Intervention done etc.)
7. STATISTICAL ANALYSIS TO BE USED FOR REPRESENTATION OF THE STUDY FINDINGS
8. EXPECTED RESULT/EXPECTED CONCLUSION
9. BIBLIOGRAPHY/REFERENCES
Important Note:
** In Case of Retrospective Studies in which MCC data is used, a written Consent of the Head of the Concerned Department/ Head of the Institute has to be taken prior to collection of the data. The copy of the Consent Letter for Hospital data collection for the purpose of research work must be attached with Research proposal & to be submitted to IRB-MCC.
The Investigators who are interested to conduct a Research at Malabar Cancer Centre are requested to make a study proposal as per the above guidelines. The Investigators must fill up a form as given in the Item No. 1 in the link below.
The filled in Investigator's Protocol Submission Form along with a hard copy of the study proposal to be submitted to the Office of IRB, Malabar Cancer Centre. A soft copy of the same proposal should be sent to irbmcctly@gmail.com. The IRB review process takes its own time following some SOPs and Investigators are requested to submit their proposals to IRB-MCC well in advance (at least 15 days prior to IRB-SRC Scheduled Meets) for smooth review process. The Investigators are directed to keep a close contact to the Office of IRB, MCC for updates/status of review.
| 4. SOPs for IRB-MCC | |
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MALABAR CANCER CENTRE Moozhikkara (P.O), Thalassery, Kannur District, Kerala, India-670103
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