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About us
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Agreements/MOUs
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Application portal
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Communication To Industry
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Forms
Guidelines
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Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Names and Scheduling
Amended Schedules
Consolidated Schedules
Guidelines
Orthodox Medicines
Communication to Industry
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Templates
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Pharmacovigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
Category A Medicines
Complementary Medicines
Medical Devices
Veterinary Medicines
Veterinary Medicines
Forms
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
OTC Toolkit
Pharma Licenced Establishments
Revoked or Suspended Pharma Licences
PI & PIL Repository
Registered Health Products
Registered Vet Products
E-Services
Adverse Drug Reaction Reporting
AEFI Reporting Dashboard
Complementary Medicines Licensing
COVI-VIG Reporting System
eCTD Submissions Portal
Health Product Application Status Checker
Health Products Variations Status Checker
Lot Release Search
Med Safety App
Mpox Monitoring
OTC Medicines Directory
OTC Toolkit
Product Variations Portal
Registered Health Products
Section 21 Applications
VET Status Checker
VET Variation Status Checker
E-Library
Acts, Regulations & Policies
Acts
Govt Gazettes And Regulations
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Corporate & Publications
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CLINICAL TRIALS APPLICATION AND REPORT FORMS
Document Number
Title
Categories
Date Updated
Version
Units
File Type
Link
doc_categories_hfilter
doc_tags_hfilter
OF-PEM-VET-01C
Veterinary Clinical Trial Application Template
Application forms
,
Form
,
Templates
26/08/2024
3
Clinical Trials
,
Veterinary medicines
docx
Download
application-forms form templates
clinical-trials veterinary-medicines
GLF-CEM-CT-01H
Safety Reporting during Clinical Trial Form
Application forms
,
Form
13/10/2022
4
Clinical Trials
docx
Download
application-forms form
clinical-trials
6.36
Investigators workload Form
Application forms
,
Form
22/04/2020
3
Clinical Trials
Download
application-forms form
clinical-trials
GLF-CEM-CT-01G
Six monthly progress report form
Form
,
Report forms
22/09/2022
5
Clinical Trials
docx
Download
form report-forms
clinical-trials
GLF-CEM-CT-01D (CTF3)
Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites
Application forms
,
Form
15/09/2022
4
Clinical Trials
docx
Download
application-forms form
clinical-trials
GLF-CEM-CT-01C (CTF2)
Application for a Protocol Amendment to an Approved Trial
Application forms
,
Form
15/09/2022
4
Clinical Trials
docx
Download
application-forms form
clinical-trials
GLF-CEM-CT-01F
2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials
Form
,
Report forms
07/09/2022
2
Clinical Trials
docx
Download
form report-forms
clinical-trials
GLF-CEM-CT-01B
Clinical Trial Application Form – Guidance in conditions of a Public Health Emergency
Application forms
,
Form
08/06/2022
2
Clinical Trials
,
Emergency use
docx
Download
application-forms form
clinical-trials emergency-use
GLF-CEM-CT-01A
Clinical Trial Application Form
Application forms
,
Form
18/09/2022
8
Clinical Trials
docx
Download
application-forms form
clinical-trials
GLF-CEM-CT-01E
Notification Studies: Phase IV
Application forms
,
Form
01/10/2023
5
Clinical Trials
docx
Download
application-forms form
clinical-trials
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