Sure, here's a summary of a global clinical trial description: - **Scope:** The clinical trial is conducted on a global scale, spanning multiple countries or regions. - **Objective:** It aims to assess the efficacy, safety, or both of a particular intervention, such as a drug, medical device, or treatment method, across diverse populations. - **Participants:** It involves a diverse participant pool, potentially including individuals from various ethnicities, backgrounds, and geographic locations, to ensure the intervention's applicability across different demographics. - **Regulatory Compliance:** The trial adheres to regulations and guidelines set forth by multiple regulatory bodies, ensuring consistency and safety in all participating regions. - **Collaboration:** Often, global trials involve collaboration between multiple research centers, institutions, or pharmaceutical companies across the globe to facilitate recruitment, data collection, and analysis. - **Logistics and Challenges:** Managing logistics, such as coordinating different time zones, language barriers, diverse healthcare systems, and varying infrastructures, presents challenges in conducting and monitoring the trial. - **Data Collection and Analysis:** Data collection and analysis procedures are standardized across sites to maintain consistency and reliability in the trial's results. - **Impact:** Results from global trials have the potential to influence medical practices and policies worldwide, providing insights into the intervention's efficacy and safety in diverse populations. #Global Clinical Trials #Clinical Research #International Trials #Healthcare Trials #Medical Research #Global Health Studies #Multinational Clinical Trials #Cross-border Studies #Pharmaceutical Trials # Clinical Trial Management Global clinical trials often fall under various categories based on their nature, focus, or the medical field they address. Here are some common categories: 1. **Therapeutic Area:** Trials can be categorized by the medical condition or disease they aim to address, such as oncology, cardiology, neurology, infectious diseases, etc. 2. **Intervention Type:** Categorization based on the type of intervention being studied, like drug trials, medical device trials, behavioral interventions, surgical procedures, or combination therapies. 3. **Phase of Clinical Trial:** Trials are typically categorized into phases (Phase I, II, III, IV) based on their stage of development and purpose, such as testing safety, efficacy, dosage, and post-market surveillance. 4. **Population Focus:** Some trials might focus on specific populations like pediatric trials, geriatric trials, trials in pregnant women, or trials in rare diseases, catering to particular demographic or medical needs. 5. **Global Health Initiatives:** Trials addressing global health challenges, like infectious disease outbreaks, pandemic responses, vaccine trials in various regions, etc. 6.

1. Presented By:
Mr. Satyajeet Rajabhau Jadhavar
R.C. Patel Institute of pharmacy
M. pharm 1st year
Regulatory Affairs
Global Clinical Trials
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2. INDEX
• Introduction to Global Clinical Trials
• Rules
• Functions of GCT
• Processes
• Organogram
• GCP inspection checklist
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3. Introduction of GCT
What is Clinical Trial?
Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate
data for discovering and/or verifying the clinical, pharmacological (including
pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of
determining safety and/or efficacy of the new drug.
What is Global Clinical Trial
Global Clinical Trial means any clinical trial which is conducted as part of multi-national
(more than one country) clinical development for designed and development for approval of a
new drug worldwide.
No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by
any institution, shall be conducted except under, and in accordance with, the permission, in
writing, of the licensing authority defined in clause (b) of rule 21.
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4. RULES GOVERNING CLINICAL TRIALS
The clinical trials are conducted in accordance with the D&C rules.
The specific rules are :
1. Rule 122 DA - Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
2. Rule 122 DAB - Provision for examination of serious adverse event (SAE) of injury and death and payment of
compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay
compensation
3. Rule 122 DAC - Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow
Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of D & C rules and
other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance;
4. Rule 122DD - Requirements and guidelines for registration of Ethics Committee;
5. Rule 122 E - Definition of new drug;
6. Schedule Y - Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
Good clinical practice guidelines issued by CDSCO, Directorate General of Health Services, Govt. of India
The handbook for applicants reviewer of clinical trials in India has been published by ICMR with CDSCO to provide clarity,
enhance transparency, and facilitate understanding of review process.
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5. Function of Global Clinical Trial Division
• Processing of applications received for conduct of Global Clinical Trials (i.e. Form 44 ), review,
approval and follow-up until end of study as per Schedule Y, Rule 122 DA, 122 DAB, 122 DAC
and 122 E under D &C rules 1945)
• Review and approval of Test License applications (Form 12 ) to import the Investigational
Medicinal Products (IMP) for GCT.
• Review of notification for Non-interventional/Observational/Academic/Investigator Initiated
Trials.
• Review and approval of post approval changes applications like Major protocol amendments &
change in sponsors/applicant etc.
• Review of notification like Minor protocol amendments, Investigator’s Brochure (IB), Informed
Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), DSUR, site
additions/deletions, change in Principal investigators/Co- investigators, Clinical Trial
Agreements, Ethics committee approval of PI sites, Annual status Reports, End of clinical trial
notifications & Clinical Study Reports (CSR) etc.
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6. •Handling of complaints, parliament questions and RTI queries related to
Global clinical trials.
•Handling/Monitoring of GCP Inspections based on the trial monitoring
documents like PSURs, ASRs, complaints received etc.
•Review & action taken in respect to GCP inspection reports received from
Inspection Team/Zonal Offices ( Show-cause notice, response of show-cause
notice, warning debarment, suspension etc.
•Data-base management (receipt/files/other misc. data including permissions
generated, maintenance of guard files of query/ approvals, parliament
questions answered, CSR etc.)
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7. Applicant
Online submission of application with
requisite documents and
Application received by
Nodal Officer
Application
forwarded to
Reviewing Officer
After review forwarded to NO
After review
forwarded to
DDA/DA
Forwarded to LA Approval
Query
Approval process for Form-44/ TL Application received Online Sugam Portal with
respect to Global Clinical Trials Division.
If any deficiency
in documents
If all the documents are in Order
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8. Organogram
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9. Application for Global Clinical Trial
1.Module I Administrative section
2.Module II : Summaries
3.Module III : CMC Data
4.Module IV : Animal toxicology data
5.Module V : Animal pharmacological data
6.Module VI : Clinical data
7.Module VII : Trial related documents
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10. • Rules
Rules Description
122 DA Approval to perform clinical trials
Rule122 DAA Clinical trial definition
Rule 122 DAB Compensation in case of trial related injury or death
Rule 122 DAC Conditions of clinical trial approval and audit
Rule 122 DD Ethics committee registration
Rule 122 E Definition of New Drugs
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11. Amendments
122 DAB First amendment
Providing free medical services to subject in
case of injury.
-In case death or injuries provide compensation
- Report requirements for serious adverse
events has been provided.
122-DAC Second amendment
- Approval for clinical trial
- Permission of ECs before trial initiation.
- Annual reports of clinical trial status.
- Audit at trial site and personnel by CDSCO to
check GCP and schedule Y compliance.
122-DD Third amendment
Ethics committee’s registration.
- Requirements and guidelines for Ethics
committee registration with application, record
maintenance.
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12. GCP INSPECTION CHECKLIST
1. Name and address of the clinical trial site
2. Date of Inspection
3. Inspection Team Members
4. Personnel present during Inspection (with name and role/designation.)
5. Address & Contact details of Investigator
6. Name & address of the Sponsor
7. Name & address of clinical trial NOC holder
8. Name & address of EC
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13. GCP INSPECTION CHECKLIST
9. Protocol Title
10. Protocol Number Version/date Protocol amendments, if any.
11. Investigational Product
12. Stage of study: (Mark the relevant) (A) Before Trial Commencement (B) During
Conduct of the trial (C) After Completion of Trial
13. Type of Inspection: Surveillance For Cause
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14. References
https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/Global-Clinical-Trial/
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