Presentations

Abstracts & Publications

Questions? Contact the Abstracts & Publications Team ACKNOWLEDGING FUNDERS Indo-US Research Sponsor Acknowledgement Language NIH Public Access Policy: Communicating and Acknowledging Federal Funding (External Link | NIH Website) ABSTRACT PRESENTATIONS Process: Notify the Abstracts & Publications Team when an Abstract is submitted and again when it is accepted Send Poster PDF files to the Abstracts & Publications Team Poster Template (MS Powerpoint | 2019-07) PUBLICATIONS CCGHE Publication Policy (PDF | 2019-07) CCGHE Publication SOP (MS Word | 2019-07) NIH PUBLIC ACCESS (PMC)...

MEETINGS & ROSTERS

Questions? Contact the Meetings & Rosters Team GoToMeeting Calls (MS Word Document | 2019-07) Staff Rosters (Coming soon) Return to Main Menu

Regulatory Guidelines & Forms

Questions? Contact the Regulatory Team ABOUT THIS SECTION The information herein is subject to revision based on regulatory changes or new requirements. Changes will be updated here and here only. This resource was developed for investigators who collaborate with BJ Government Medical College (BJGMC) and Johns Hopkins University, and is not intended for external distribution . Links are provided as a guide for navigating the process of obtaining all approvals needed to conduct clinical research in India. IRB APPROVAL PROCESS BY STUDY CATEGORY | Updated 2019-08 Each study type lists relevant...

Research Forms & Agreements

Documents linked below are the latest versions on file, and should be tailored for specific research protocol needs Questions? Contact the Research Team BJGMC-JHU CRS SOP for Resuming On-Site Research Activities (PDF | 2020-05) MTA Guidelines (Coming soon) CTRIUMPh Data Sharing Agreement Template (MS Word Document | 2019-11) Sample Shipment Form (External Link | Google Form) Return to Main Menu

Travel

Questions? Contact the Travel Team PUNE STAFF & NON-EMPLOYEE TRAVEL PROCESS Pune Staff and Non-Employee Travel Policies (PDF | 2019-12) Travel Expense Report Form (MS Excel Worksheet | 2019-12) Missing Receipt Affadavit (PDF | 2019-12) Return to Main Menu

CONTACTS

PUBLICATIONS TEAM Molly Bowen: molly.bowen@jhmi.edu REGULATORY TEAM (U.S.) Matt Riesner: mriesne1@jhu.edu (India) Smita Nimkar: nsmita13@gmail.com (India) Nikhil Tapadia: nikhil.tapadia@outlook.com GRANTS DEVELOPMENT TEAM Samyra Cox: scox26@jhmi.edu FINANCE TEAM Sagar Bhagwat: sbhagwa4@jhmi.edu Gabriela Smit: gsmit1@jhmi.edu MEETINGS & ROSTERS TEAM CCGHE-CALLS@jhmi.edu Ana Cervantes: acervan4@jhmi.edu RESEARCH TEAM MTA Guidelines: Sagar Bhagwat: sbhagwa4@jhmi.edu Data Sharing Agreement: Alison Pack: apack@jhmi.edu Sample Shipment: Alison Pack: apack@jhmi.edu TRAVEL & REIMBURSEMENT...

CCGHE Newsletter Archive

Questions or Ideas for Submission? Contact the Communications Team VOLUME 1 (PDF Files) June: Issue 1 (2019-06-05) July: Issue 2 (2019-07-12) August: Issue 3 (2019-08-05) September: Issue 4 (2019-09-06) November: Issue 5 (2019-11-26) January: Issue 6 (2020-01-15) February: Issue 7 (2020-02-18) Return to Main Menu

Clinical Trial Submission Requirements

Timeline: Variable Forms: FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) Submission Package Requirements Cover Letter (signed by site PI) Research Protocol Informed Consent/Assent forms (English, Marathi, and Hindi and applicable translation certifications) Package Inserts/Investigator Brochures Budget/Contract Insurance Principal Investigator CV Case Report Forms (CRFs) PI Undertaking Recruitment Documents Other Research-related documents to be Shared with Participants If your institution...

Clinical Trial Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover Letter (signed by site PI) Research Protocol Informed Consent/ Assent forms (English, Marathi, and Hindi and applicable translation certifications) Package Inserts/Investigator Brochures Budget/Contract Insurance Principal Investigator CV Case Report Forms (CRFs) PI Undertaking Recruitment Documents Other Research-related documents to be Shared with Participants Return to Regulatory...

Observational Study Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover letter (signed by site PI) Research Protocol Informed Consent/ Assent forms (English, Marathi, and Hindi and applicable translation certifications) Budget/Contract Principal Investigator CV PI Undertaking CRFs Recruitment Documents Return to Regulatory Main Page

Retrospective Chart Review Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover letter (signed by site PI) Research Protocol Budget/Contract Principal Investigator CV CRFs Return to Regulatory Main Page

Use of Stored Samples Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover letter (signed by site PI) Research Protocol Budget/Contract Principal Investigator CV PI Undertaking CRFs Return to Regulatory Main Page

Qualitative Study, Implementation Science, Psychosocial Assessment Review Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover letter (signed by site PI) Research Protocol Informed Consent Forms (English, Hindi and Marathi with translation certification, as applicable) Budget/Contract Principal Investigator CV Questionnaire Data Collection Form Return to Regulatory Main Page

RePORT Consortium Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover Letter (signed by site PI) Research Protocol Informed Consent/ Assent forms (English, Marathi, and Hindi and applicable translation certifications) Budget/Contract Principal Investigator CV PI Undertaking Case Report Forms Return to Regulatory Main Page

Annual Review: Clinical Trial Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover Letter (signed by site PI) Progress Report Research Protocol Informed Consent/ Assent forms (English, Marathi, and Hindi and applicable translation certifications) Package Inserts/Investigator Brochures Budget/Contract Other Documents, as needed Return to Regulatory Main Page

Annual Review: Observational Study Submission Requirements

TIMELINE Variable FORMS FORM 1: Study Protocol Development Template (MS Word | 2019-08) FORM 2: Hopkins IRB Submission Checklist for International Research (MS Word | 2019-08) SUBMISSION PACKAGE REQUIREMENTS Cover Letter (signed by site PI) Progress Report Research Protocol Informed Consent Form Other Documents, as needed Return to Regulatory Main Page

Indo-JHU Regulatory Team Review

Questions? Contact the Regulatory Team TIMELINE 3 Weeks Prior to BJGMC Ethics Committee Meeting RESOURCES BJGMC Ethics Committee Meeting Calendar (MS Excel Spreadsheet | 2019-08) Submit the completed protocol package to the Regulatory Team , who reviews the submission for India Ethics Committee compliance and works with investigators on revisions needed for EC approval. Return to Regulatory Main Page

Indian Ethics Committee Approval

Questions? Contact the Regulatory Team TIMELINE 1-2 Months from Submission to Approval RESOURCES BJGMC Ethics Committee Meeting Calendar PROCESS The BJGMC Ethics Committee reviews all proposals for research at the clinical site. The Committee meets the second or third week of every month (EC calendar is linked above; confirm date with the Regulatory Team member for India). EC approval is required before proceeding with HMCS, DBT, DCGI, and JHU submissions. Submit both hard copies and soft copies of the packet. If the packet is not complete or there are discrepancies, the submission packet...

ICMR/HMSC Approval

Questions? Contact the Regulatory Team TIMELINE 6-9 Months from Submission, and even up to a year. Following EC approval, promptly submit the application for ICMR/HMSC approval. The HMSC meets in February, April, June, August, October, and December of each year. Proposals must be submitted by the 15th of the previous month in order to be included in the HMSC agenda (Per HMSC letter, File No: lN DO/F R C/442/2017-|HD, dated 17th January 2020). FORMS FORM 3: Format for the Research Project FORM 4: Indian Council of Medical Research Format of Summary Sheet for New Project Proposals Involving...

DCGI Approval and Drug Importation 

TIMELINE for D CGI Approval & License Import 3-4 months from Submission to Approval TIMELINE for Drug Importation 15 days after order has been placed PROCESS DCGI permission is NOT required to conduct clinical trials intended for academic purposes that will use drugs with already approved formulations. In order to conduct any foreign-funded clinical trial involving drugs in India, an approval from the Drugs Controller General of India (DCGI) is necessary. New Drugs and Clinical Trials Rules, 2019 is released on 20-March-2019. The rules shall apply to all new drugs, investigational new...

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