CLINICAL RESEARCH SECRETARIAT

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Tata Memorial Centre (TMC) – Clinical Research Secretariat (TMC-CRS) is a premier cancer research department where research studies— Investigator-Initiated Research (IIR), Pharma-sponsored Clinical Trials (Interventional/Observational), Academic Collaborations (National/International), Epidemiological and Translational Studies are managed through a structured framework to ensure scientific integrity, regulatory compliance, and patient safety. Clinical Research Secretariat (CRS) functions as the central coordinating body for all clinical research activities.

Since its establishment in 2003, the Clinical Research Secretariat (CRS) has been the backbone of TMC’s clinical research activities. CRS supports investigator-initiated and regulatory trials, training programs, annual Evidence-Based Medical (EBM) meetings, and multi-centre collaborations across all Disease Management Groups (DMGs) & Departments —Adult Hematolymphoid, Breast, Head & Neck, Gastrointestinal (GI), Gynaecologic Oncology, Thoracic, Neuro-oncology, Uro-oncology, Pediatric (Hemato Lymphoid & Solid Tumors) Oncology and Bone & Soft Tissue cancers and Dept. of Anaesthesiology, Critical Care and Pain

Following steps should be followed for conducting and management of studies in TMC to ensure that all the studies has been conducted as per the national & International guidelines;

Conception, Planning & Feasibility

• Protocol Development: Investigators initiate study conception, planning, and drafting of the protocol based on the defined research question.
• Site Feasibility: It is imperative for the investigators to assess the feasibility of conducting the protocol at the site, considering patient pool, infrastructure, departmental capacity, institutional policies and budget requirements. This applies to both Investigator-Initiated and Sponsored studies.
• DMG Review: The research protocol should be discussed within the respective Department and Disease Management Group (DMG)/ Working Group to ensure scientific integrity and obtain necessary internal approvals to process the study for IEC approval.

Research Mentor Group (RMG)

TMC has introduced a Research Mentor Group (RMG) to support new researchers in protocol development and study conduct. The RMG provides guidance on study design, methodology, statistical planning, and related aspects. Researchers may also approach the group post-IEC approval for clarification or protocol modifications. In cases where modification is required, the DMG convenor or secretary/ Head of the Department may direct investigators to route the protocol through the RMG for review and refinement.

Budgeting & Legal Agreements

• Budget Preparation: Draft study budgets for both Investigator-Initiated Trials (IITs) and Sponsored Clinical Trials, ensuring alignment with institutional policies and funding requirements.
• Agreement Review & Finalization: All study-related legal agreements should be finalized and reviewed as per IEC SOP, including:
  • Clinical Trial Agreements (CTA)
  • Material Transfer Agreements (MTA)
  • Memoranda of Understanding (MoU) with collaborators
  • Confidentiality/Disclosure Agreements (CDA), if applicable
• Approval Pathway: The IEC has developed a structured pathway for processing MoU/CTA/CDA/MTA. Investigators are advised to follow this pathway to facilitate smooth processing and obtain timely approval from the TMC Legal Department.
• Reference: Review Pathway and Legal Review Form Link

Regulatory & Ethics Submissions

• EC Submission: Research proposals must be submitted to the Institutional Ethics Committee (TMC-IEC) portal after internal department and DMG approvals.
• Required Documents: Ensure that all relevant documents are complete and submitted, including but not limited to :
  • Study Protocol
  • Informed Consent Form (ICF) and Child Assent Form (applicable for pediatric populations) in both English and the local language(s)
  • Case Report Form (CRF)
  • Investigators Brochure ( Applicable only for pharma studies)
  • Lay Summary
  • Any additional documents as required by the protocol
  • DCGI approvals (if applicable) should be submitted to IEC
  • Current and updated CV, Valid GCP training certificate and MMC certificate (if applicable) of all the study team members.
  Kindly refer Link : for Detailed procedure for project submission to IEC for approval.



HMSC Clearance and Institutional Sensitivity/Security Review

1. DAE Sensitivity/Security Clearance

As per DAE Order 1305/5/2021/R&D-II/DAE/6922 dated 16 June 2021, all foreign collaborative research proposals from aided institutions must undergo mandatory sensitivity/security review. The Director, TMC, has constituted a Sub-committee under the Foreign Collaborative Research Sub-Committee (FCRSC) to review all proposals involving foreign collaboration. The committee’s recommendations will be forwarded to DAE through the Director (Administration) and placed before the TMC Governing Council for information and further approval.

2. MoHFW Requirements for International Life Sciences Research

MoHFW Order Z-21022/55/2022-PH dated 27 June 2022 requires all Central/State Government institutions conducting international research in the life sciences (humans, animals, plants, environment) to obtain approvals from the concerned line Ministry of the Government of India. Proposals involving biosafety, biosecurity, national sensitivity/security issues, or transfer of biological materials must be forwarded to the appropriate Ministry for clearance.

3. BioRRAP Portal Registration

The Biological Research Regulatory Approval Portal (BioRRAP) of DBT serves as a single-window platform for regulatory information and approvals. Each international research proposal receives a unique BioRRAP ID, which is mandatory before initiating any Ministry or HMSC review. PIs must register their proposals on the BioRRAP portal as per DBT OM PID-99/22/2021-PPB-DBT-Part(2) dated 17 June 2022.

4. TMC Sub-committee’s Role in Facilitating HMSC Clearance

• Screen proposals for sensitivity/security considerations.
• Guide PIs in preparing documentation for DAE, HMSC, and relevant Ministries.
• Confirm BioRRAP registration and verify BioRRAP ID.
• Coordinate submission of recommendations to DAE and support HMSC processing.
• Serve as the institutional link between the PI and national regulatory authorities.

This guideline ensures that all international collaborative research proposals from TMC meet national regulatory, sensitivity, and biosecurity requirements, while providing structured institutional support for timely HMSC clearance.

• CTRI Registration: All studies must be registered on CTRI after IEC approval as mandated and recommended by IEC in the IEC approval letter. Please refer Guideline to register study on CTRI for detailed instruction.
• SUGOM Portal: For interventional pharma studies; one should ensure that the sponsors have added and mapped the site investigator under the registered trial and the trial team has been trained for the same.

Study Initiation

• Post-Approval Planning: Once IEC approval is received, the Investigator should plan and organize a study initiation meeting at the site.
• Team Training: The Investigator must brief the study team on the protocol, study conduct, responsibilities, and timelines. PI should also make sure that the organized study team is adequately trained by CRO/Sponsor wherever applicable.
• Inter-Departmental Communication: PI should inform all relevant departments (e.g., pathology, radiology, pharmacy, nursing, and laboratory) in advance about the initiation of the study and their role in study-related procedures.
• Investigational Product (IP) Verification: For studies involving Investigational Products, ensure IP availability and accountability procedures are in place prior to study initiation and arrival of IP at the storage site.

Study Conduct & Monitoring

• Recruitment & Consent: Patient recruitment and informed consent must be carried out in strict adherence to the study protocol, CRS SOPs, and applicable regulatory guidelines.
• Essential Documentation: : The Investigator must maintain accurate and up-to-date study records, including:
  • All the approved documents from IEC including; Protocol, ICF/assent forms in all available languages, MoU/CTA, IB (all the documents that are applicable)
  • Screening logs/Eligibility Checklist
  • Randomization logs
  • Source documents and clinical notes
  • Duty Delegation Log
  • Drug accountability log
  • Reimbursement log
  • SAE and Adverse Event (AE) reports with supporting documentation & records
  • Case Report Forms (CRFs)
  • Documentation and submission of deviations/violations (if any)
  • Annual study updates/reports to IEC, as per IEC SOP
  • Trial Master File (TMF)/Investigator Site File (ISF)
  • All documents related to study amendments
• Monitoring:
  • Internal Monitoring: Conduct internal monitoring periodically & the Research Review Committee (RRC) will conduct the monitoring as per SOPs.
  • Sponsor Monitoring: Performed according to sponsor-specific monitoring plans and policies.

Data Management & Documentation

• Data Handling: Data entry, quality checks, and query resolution should be coordinated among Investigators, Clinical Research Coordinators (CRCs), and Sponsors/CROs.
• Data Readiness: Data should be prepared and maintained as per the protocol to ensure accuracy and completeness for statistical analysis.
• Confidentiality & Security: Patient and trial data must be handled securely, ensuring confidentiality and compliance with regulatory and institutional requirements.

Study Close-Out & Archiving

• Study Completion Activities:
  • Submission of study close-out report to the IEC.
  • Preparation and submission of the final study report.
• Archiving: The CRS ensures systematic archiving of essential study documents in accordance with regulatory guidelines and CRS policy.

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What is an Informed Consent Form (ICF)

An Informed Consent Form (ICF) is a written document used in clinical research practice to ensure that participants (or their legal representatives) are fully informed about a study or procedure before voluntarily agreeing to take part. It is both an ethical requirement and a legal document that protects the rights, safety, and well-being of participants.

What are the Key Principles of ICF

• Written in simple, non-technical languageunderstandable to lay persons or children in case of child assent form in studies involving pediatric population.
• Must be translated into local languages and back-translated for accuracy.
• Should cover all essential elements of consent as per ICMR, GCP & regulatory guidelines.

Elements of ICF (As per ICMR guideline)

Steps for Drafting ICF

• Use the template provided by IEC/ICMR/Sponsor as base.
• Simplify medical jargon, ensure readability (8th-grade level).
• Prepare short form + long form where applicable.
• Translate into regional languages and validate.
• Ensure Ethics Committee approval before implementation.

Note: For detailed information, please refer CRS & IEC SOP.

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What is a Case Report Form (CRF)

A Case Report Form (CRF) is a structured document designed to capture all protocol-required information about each trial participant. It ensures uniform data collection across sites and compliance with Good Clinical Practice (GCP) and all regulatory requirements.

What are the Key Principles of CRF

• Should reflect the study protocol objectives, endpoints, and procedures data.
• Must be clear, concise, and user-friendly for investigators and CRCs.
• Capture only relevant and essential data (avoid unnecessary fields).
• Maintain consistency with data requirement for result analysis.

Steps for Drafting CRF

Review Study Protocol

• Identify objectives, endpoints, inclusion/exclusion criteria, visit schedule, and safety assessments.

Define Data Points

• Demographics (age, sex, etc.)
• Medical history & concomitant medications
• Baseline assessments
• Study treatment details (dose, route, timing)
• Follow-up assessments
• Adverse events and outcomes
• Review your protocol for data to be captured for data analysis

Design Format

• Use visit-based structure (Screening, Baseline, Follow-up, End of Study).
• Standardize response fields (e.g., Yes/No, tick boxes, coded values).
• Ensure clarity in instructions to avoid ambiguity.
• Allow for audit trail in electronic CRFs (eCRFs).

Quality Check

• Cross-check with protocol and Statistical Analysis Plan.
• Pilot-test with finalization.

Note: For detailed information, please refer CRS & IEC SOP

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Introduction

• The Clinical Trials Registry–India (CTRI) is open source, online public record system for registering clinical trials conducted in India.
• Introduced on 20 July 2007 and hosted by the ICMR’s National Institute for Research in Digital Health and Data Science.
• Serves as India’s Primary Registry recognized by the World Health Organization’s International Clinical Trials Registry Platform (WHO-ICTRP).
• The Drugs Controller General of India (DCGI) has made prospective trial registration on the CTRI mandatory before the enrollment of the first participant.
• The registry captures essential information about a trial, including investigators, sponsors, interventions, study sites, and timelines, ensuring transparency, accountability, and public access to clinical research data.

Which Trials Should Be Registered?

• Drugs, surgeries, devices, rehabilitation strategies
• Behavioral or lifestyle changes
• AYUSH treatments
• Post-marketing surveillance trials
• Bioavailability/Bioequivalence (BA/BE) trials
• Postgraduate thesis studies involving human participants
• Multi-country trials that include India
• Prospective Observational Studies
• Any trial recommended by the Institutional Ethics Committee (IEC) for registration

When to Register

• After receiving IEC approval
• Before enrolling the first participant in your study

Required Documents

• Ethics Committee Approval Letter
• DCGI approval (if applicable)
• Study protocol with:
  • Objectives
  • Primary / Secondary outcome
  • Target sample size
  • Inclusion and exclusion criteria
  • Methodology
  • Timelines
  • Trial-related details: investigators, sites, sponsors, funding sources
  • Contact details of primary study team members (phone, email, address)

Steps to Register a Study

Step 1 – Create an Account

• Visit www.ctri.nic.in
• Click New User Registration and create a login ID

Step 2 – Log In and Access Trial Registration

• Use your registered login ID
• Go to Register Trial section

Step 3 – Fill in the Trial Registration Form

• Study title
• Principal investigator’s name and contact details
• Study type
• Target population and sample size
• Intervention details
• Inclusion and exclusion criteria
• Study start and end dates
• Funding source and sponsors

Step 4 – Upload Required Documents

• Ethics approval letter
• DCGI approval letter (if applicable)
• Other regulatory permissions (if any)

Step 5 – Review and Submit

• Check completeness and accuracy
• Submit form online
• Receive a Reference Number

Step 6 – CTRI Review Process

• CTRI administrators review your submission
• Clarifications/corrections may be requested
• Upon approval, you receive a CTRI Registration Number

E-Tutorials for Trial Registration

• Introduction to CTRI
• New Applicant Registration
• Step-by-step trial registration
• Trial submission process
• Common errors in trial upload and submission
• Trial review workflow
• Updating trials sent back after review

After Registration

• Status changes (recruiting, completed, stopped)
• Protocol amendments
• Results once available
• Updates are visible to the public for transparency

Key Points to Remember

• Register before enrolling participants
• Ensure details match protocol and ethics approval
• Update CTRI for any changes(e.g. amendments, Site addition, PI change, etc)
• Registration facilitates publication in reputed journals

Quick Links

• CTRI Home: www.ctri.nic.in
• ICMR–NIMS: nims.icmr.org.in

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A clinical research study proposal is a structured plan outlining the rationale, objectives, methodology, and expected outcomes of a research project. The proposal should be scientifically important for securing appropriate approvals, funding, and ensuring a scientifically sound study.

A good protocol starts with a strong idea and ends with a clear, feasible plan that can be executed exactly as written in the protocol.

Following steps should be considered while writing a protocol:

Establish a Strong Research Rationale

Before drafting a protocol, ensure that your research idea has a clear scientific basis. Your study should aim to:

• Bridge a knowledge gap in the field.
• Explore a new or under-researched area.
• Validate or challenge previous findings using a larger or more robust study design.

Why this matters: Without a strong rationale, the study may fail to gain ethics approval or funding. Review whether your idea genuinely adds to existing knowledge.

Define the Research Question & Objectives

The research question is the important part of your study. It should be specific, focused, and answerable. Consider the FINER criteria (Feasible, Interesting, Novel, Ethical, Relevant). Clearly state primary and secondary objectives, and define your hypothesis.

• What is the clinical problem?
• Does it meet the FINER criteria?
  • Feasible
  • Interesting
  • Novel
  • Ethical
  • Relevant
• What are your primary and secondary objectives?
• What is your hypothesis?

Example:

• Research Question: Does Drug X reduce symptoms in patients with Disease Y compared to placebo?
• Primary Objective: Evaluate Drug X’s effect over 12 weeks.
• Secondary Objective: Assess its safety profile.

Why this matters: If your question is too broad or vague, the study risks becoming unmanageable or inconclusive.

Conduct a Literature Review

Review existing knowledge and identify gaps your study will address. A strong literature review demonstrates understanding of the field and justifies the need for your research.

• Shows you understand the field.
• Demonstrates why your study is necessary.
• Helps refine your methodology.

Why this matters: Reviewers and funders want to see that your work builds logically on what is already known.

Describe the Study Design & Methodology

Explain in detail the design and how the study will be carried out. Following points should be considered while drafting the study design and methodology:

• Study type: RCT, cohort, cross-sectional, case-control, etc.
• Population: Inclusion and exclusion criteria.
• Intervention & comparator: Dosage, frequency, mode of administration.
• Outcomes: Clearly define primary and secondary endpoints.
• Sample size calculation: Include justification.
• Follow-up plan: Timing and frequency of assessments.
• Randomization & blinding: If applicable, describe the process.

Why this matters: Clarity here ensures the study is reproducible and minimizes bias.

Address Ethical Considerations

Ethics must be central to the protocol. Hence while drafting the protocol one should ensure that the patient’s right, safety and confidentiality of patients is protected by ensuring the following points:

• Detailed Informed Consent Form available in English and local language.
• How you will obtain informed consent.
• Plan for IEC (Institutional Ethics Committee) approval.
• Measures for participant safety and monitoring.
• Data protection and privacy compliance.

Why this matters: Unethical studies risk rejection by ethics committees and can compromise both participant safety and the credibility of the research team.

Develop the Statistical Analysis Plan

Detail information on how you will analyze the data, including your justification and methods used for sample size.

• Statistical tests for each endpoint.
• How you will handle missing data.
• Interim analysis plans.
• Subgroup analyses (if planned).

Why this matters: A well-planned statistical section avoids biased interpretations and strengthens credibility.

Create a Project Timeline

Provide a realistic schedule of activities from start to finish. Using a Gantt chart is highly recommended.

Prepare a Detailed Budget

Budget all the expenses that will be required during the conduct of entire study. To complete the study with the planned budget requires futuristic and realistic budget planning.

• Personnel salaries.
• Laboratory or imaging tests.
• Equipment or drug costs.
• Data management and software.
• Travel, logistics, and contingencies.
• IEC Fees (Applicable only for pharma sponsored studies)
• Institutional Over heads (Applicable only for pharma sponsored studies)
• Applicable taxes for pharma sponsored studies
• Archival charges (Applicable only for pharma sponsored studies)

Reference Your Sources

Use a consistent citation style (e.g., Vancouver or APA) for all literature and supporting documents. This demonstrates academic integrity and credibility.

Note: A well-written protocol should be so clear that another researcher could replicate your study without asking you a single question. Treat it like a recipe — precise, complete, and easy to follow.

Details of documents to be included in the protocol (ICMR 2017)