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Home - Protocol Guidelines

Protocol Guidelines

Any Research protocol/Research study proposal in which MCC-PGIOSR patient data is utilized or MCC-PGIOSR is involved as a site must be presented to Institutional Review Board (IRB)-MCC-PGIOSR 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-PGIOSR 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-PGIOSR.

The Investigators who are interested to conduct a Research at Malabar Cancer Centre-Post Graduate Institute of Oncology Sciences and Research 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-Post Graduate Institute of Oncology Sciences & Research. 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-PGIOSR for updates/status of review.

1. Protocol submission Form to IRB-MCC-PGIOSR for Investigators

2.Guidelines for devising Informed Consent Document

3.Study Completion Report (SCR) Form

4. SOPs for IRB-MCC-PGIOSR
 ------- SOP 1/VER 1
  SOP 2/VER 1
  SOP 3/VER 1
  SOP 4/VER 1
  SOP 5/VER 1
  SOP 6/VER 1
  SOP 7/VER 1
  SOP 8/VER 1
  SOP 9/VER 1
  SOP 10/VER 1
  SOP 11/VER 1
  SOP 12/VER 1
  SOP 13/VER 1
  SOP 14/VER 1
  SOP 15/VER 1