Presentations

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

ABSTRACTS & PUBLICATIONS TEAM Alison Pack: CCGHEPublications@jhmi.edu REGULATORY TEAM (U.S.) Matt Riesner: mriesne1@jhu.edu (India) Smita Nimkar: nsmita13@gmail.com GRANTS DEVELOPMENT TEAM Alison Pack: apack@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 TEAM Ana Cervantes: acervan4@...

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...

DBT No Objection Certificate

TIMELINE 4-5 Weeks from s ubmission to approval GUIDELINES DBT NOC is required for RePORT studies only. DBT approval is in lieu of ICMR/HMSC approval. It must be requested by an Indian investigator. Projects may be submitted for DBT NOC in tandem with seeking local EC approvals. As a nodal agency of the VAP, the DBT is authorized to review projects for alignment with VAP program priorities and to provide approval. To request DBT NOC for RePORT India-related studies, the Indian PI for the proposed project must email Dr. Jyoti Logani ( jyoti.logani@nic.in ), Scientist-E, DBT a summary of the...

Importation of Test Kits & Reagents

Documents linked below are the latest versions on file, and should be tailored for specific research protocol needs Questions? Contact the Research Team Timeline: 4-6 Months from Submission to Approval Research studies requiring medical devices (test kits and reagents) are generally approved by the U.S Food & Drug Administration (FDA) when used for an IND study. When the required test kit or reagent is not available in India, and the vendor does not possess the license to import it, complete an online application via the Central Drugs Standard Control Organization (CDSCO) Online System...

Importation of Test Kits & Reagents

Questions? Contact the Research Team TIMELINE 4-6 Months from Submission to Approval GUIDELINES Research studies requiring medical devices (test kits and reagents) are generally approved by the U.S Food & Drug Administration (FDA) when used for an IND study. When the required test kit or reagent is not available in India, and the vendor does not possess the license to import it, complete an online application via the Central Drugs Standard Control Organization (CDSCO) Online System for Regulation of Medical Devices Contact Vandana Kulkarni with questions. Return to Regulatory Main Page

Johns Hopkins IRB Approval

Questions? Contact the Regulatory Team TIMELINE 1-2 Months from Submission to Approval GUIDELINES IRB approvals are required from Johns Hopkins and the institution with which you are affiliated. Check with the Regulatory Team if you have questions. Submission to the Hopkins IRB requires BJGMC EC approval and any other partnerhing institutions. Hopkins IRB submissions are prepared by JHU members of the regulatory team, with input from investigators Refer to the Johns Hopkins School of Medicine IRB Submission Checklist for International Research for a detailed list of requirements. SUBMISSION...

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