training session: enhanced prism e-services · crm notification for regulated trials note: •if...
TRANSCRIPT
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Copyright © HSA, All rights reserved
TRAINING SESSION:
ENHANCED PRISM E-SERVICES
CRM NOTIFICATION SUBMISSION
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Copyright © HSA, All rights reserved
OUTLINE
1. Overview of CRM Notification Requirements
2. CRM Notification for Clinical Research Not Regulated by HSA
3. Amendment of CRM Notification (clinical research not regulated by HSA)
4. Extension of CRM Notification (clinical research not regulated by HSA)
5. CRM Notification for Regulated Clinical Trials (New and Amendment)
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CRM REGULATIONS
CRM
REGULATIONS
Health Products (Therapeutic
Products as Clinical Research
Materials) Regulations
Medicines (Medicinal Products as
Clinical Research Materials)
Regulations
Relevant provisions under the
Health Products (Medical Devices)
Regulations,
incorporating the
Health Products (Medical Devices)
(Amendment) Regulations 2016
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CLINICAL RESEARCH MATERIALS (CRM)
Clinical Research Materials (CRM)
Registered or
unregistered
therapeutic
product (TP)
Licensed or
unlicensed
medicinal
product (MP)
Placebo Medical Device
(MD)
Manufactured, imported or supplied for the purpose of being used
in any clinical research in accordance with a research protocol
Regulated Clinical Trials
Clinical Trials requiring a
CTA/CTN/CTC
Clinical Research not regulated by HSA
• Observational clinical trials of TP and MP;
• Clinical research for which TP or MP is not the
subject of investigation
• Medical device clinical trials; or
• Food and nutrition studies involving the use of MD
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•
CRM NOTIFICATION~ Facilitates access to CRM
Activity Licence CRM Notification
Manufacture of CRM Manufacturer’s LicenceNot required
CRM Notificationrequired prior to supply
of CRM by local manufacturer
Import of CRM Importer’s LicenceNot required
CRM Notification required prior to import
of CRM
Wholesale of CRM Wholesaler’s LicenceNot required
-
Supply of CRM Product RegistrationNot required
-
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CRM NOTIFICATIONRegulated clinical trials vs. other clinical research
Clinical research not regulated by HSA
Regulated clinical trial
Drafter of CRM notification form
Importer or local manufacturer Sponsor (on behalf of importer or local manufacturer)
Notification Form(PRISM)
CRM Notification form Part of CTA/CTN/CTC application form
Endorsement Workflow
Importer/Local manufacturer –> Sponsor
Sponsor -> Importer/LocalManufacturer (endorsement)
Submitter Importer or local manufacturer Sponsor (on behalf of importer or local manufacturer)
Acknowledgmentnotification
Importer, local manufacturer, sponsor
Importer, local manufacturer, sponsor
Validity period of notification
1 year from the date of notification
Duration of the clinical trial
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OUTLINE
1. Overview of CRM Notification Requirements
2. CRM Notification for Clinical Research Not Regulated by HSA
3. Amendment of CRM Notification (non-regulated clinical research)
4. Extension of CRM Notification (non-regulated clinical research)
5. CRM Notification for Regulated Clinical Trials (New and Amendment)
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•
CRM NOTIFICATIONFor Clinical Research Not Regulated by HSA
A. Import / Supply by Local Manufacturer of CRM for Clinical Research Not Regulated by HSA
Sponsor
Manufacturer(s) / Importer (s)
HSA
1. Manufacturer/Importer applicant drafts CRM notification, sends for endorsement.
2. Draft notification endorsed by sponsor.
3. After endorsement, manufacturer/importer applicant submits notification
4. CRM notification acknowledgement sent to manufacturer(s)/importer(s) and sponsor
[Sponsor Declaration]
[Manufacturer / Importer Declaration]
CRM Notification Acknowledgement
Manufacturer(s) / Importer (s)
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CRM NOTIFICATION FORM
Application Type (New or Amendment)
1 IntroductionParticulars of Importer/Local Manufacturer
2 Particulars of Clinical Research
3 Particulars of Clinical Research Material (CRM)3.1 Medicinal / Therapeutic Product3.2 Medical Device for Investigational Purpose3.3 Medical Device for Non-Investigational Purpose
4 Supporting Documents
5 Declaration & Confirmation
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eServices>Health Products Regulation>PRISM>Clinical Trials>CorpPass
login>Submit>Select Company
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Copyright © HSA, All rights reserved
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APPLICATION TYPE
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Section 1. INTRODUCTION
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Section 1. PARTICULARS OF IMPORTER/LOCAL
MANUFACTURER
Only NRIC of applicant with submitter rights will be auto-populated from login. NRIC will be masked subsequently e.g. SXXXXXX1G
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Section 2. PARTICULARS OF CLINICAL
RESEARCH
Note:(A) 2.1.1 = Single Sponsor
- Particulars of sponsor and research study mandatory
(B) 2.1.1 = Multiple Studies with Single Sponsor
- Particulars of sponsor mandatory, particulars of research studies non-mandatory
(C) 2.11 = Multiple Studies with Multiple Sponsors
- Particulars of sponsor (mandatory only if identified), particulars of research studies
non-mandatory
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Section 2. PARTICULARS OF CLINICAL
RESEARCH
Click “Save” button after entering particulars.
Sponsor endorsement email will be sent to this email address.
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Section 3. PARTICULARS OF CLINICAL
RESEARCH MATERIALS (CRM)3.1 Medicinal / Therapeutic Product
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Section 3. PARTICULARS OF CLINICAL
RESEARCH MATERIALS (CRM)3.2 Medical Device for Investigational Purpose
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Section 3. PARTICULARS OF CLINICAL
RESEARCH MATERIALS (CRM)3.2 Medical Device for Non-Investigational Purpose
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Section 4. Supporting Documents
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Section 5. Declaration and Confirmation
For Sponsor Endorsement
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Sponsor Endorsement
• Email to Sponsor(s), copied to CRM importer/manufacturer applicant
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Sponsor Endorsement Form
• Sponsor logs in using CorpPass, can view entire form and edit particulars of clinical research
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Sponsor Endorsement Form
• Sponsor Declaration
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When Sponsor endorsement completed
• Email to CRM importer/manufacturer applicant
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Application Submission after Sponsor Endorsement
• Retrieve application from Track@PRISM
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CRM-N Acknowledgement
• To CRM Importer/Manufacturer, copied to Sponsor
1 year validity period
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CRM-N Retrieval from Enquire@PRISM
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CRM-N Retrieval from Enquire@PRISM
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Copyright © HSA, All rights reserved
OUTLINE
1. Overview of CRM Notification Requirements
2. CRM Notification for Clinical Research Not Regulated by HSA
3. Amendment of CRM Notification (non-regulated clinical research)
4. Extension of CRM Notification (non-regulated clinical research)
5. CRM Notification for Regulated Clinical Trials (New and Amendment)
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AMENDMENT OF CRM-N (NON-REGULATED RESEARCH)
Note:1. Can amend particulars of CRM and/or add new CRM
sponsor, but cannot remove existing sponsors and CRM.2. CRM Sponsor endorsement process will only be triggered
when new CRM Sponsor is added.3. CRM Sponsor endorsement not required for any other
amendments to CRM-N.
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Copyright © HSA, All rights reserved
OUTLINE
1. Overview of CRM Notification Requirements
2. CRM Notification for Clinical Research Not Regulated by HSA
3. Amendment of CRM Notification (non-regulated clinical research)
4. Extension of CRM Notification (non-regulated clinical research)
5. CRM Notification for Regulated Clinical Trials (New and Amendment)
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EXTENSION OF CRM-N (NON-REGULATED RESEARCH)
Introduction (Select CRM-N to Extend)
1 Particulars of CRM-N
2 Applicant Particulars
3 Reason for extension of CRM-N
4 Supporting Documents
5 Confirmation
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Section 1. PARTICULARS OF CRM-N
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Copyright © HSA, All rights reserved
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Section 2. APPLICANT PARTICULARS
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Section 3. REASONS FOR CRM-N EXTENSION
Section 4. SUPPORTING DOCUMENTS
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Section 5. CONFIRMATION
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Copyright © HSA, All rights reserved
OUTLINE
1. Overview of CRM Notification Requirements
2. CRM Notification for Clinical Research Not Regulated by HSA
3. Amendment of CRM Notification (non-regulated clinical research)
4. Extension of CRM Notification (non-regulated clinical research)
5. CRM Notification for Regulated Clinical Trials (New and Amendment)
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Copyright © HSA, All rights reserved
•
CRM NOTIFICATIONFor Regulated Clinical Trials (i.e. requiring CTA / CTN / CTC)
B. Import / Supply by Local Manufacturer of CRM for Regulated Clinical Trial
Sponsor Applicant
Other Sponsor(s), if any
Principal Investigator(s)
Manufacturer(s) / Importer (s), if any
IRB(s)
Sponsor Applicant
HSA
1. Sponsor applicant drafts CTC/CTA/CTN application, sends for endorsement.
2. Draft application endorsed by relevant parties.
3. After endorsement, sponsor applicant submits application.
4. CRM notification acknowledgement sent to manufacturer(s)/importer(s) and sponsor upon application submission.
5. HSA issues CTC/CTA/CTN acceptance.
[Other Sponsor, PI, Manufacturer / Importer Declaration]
[Sponsor Applicant Declaration]
Issue CTC/CTA/CTN acceptance
CRM Notification Acknowledgement
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CTA/CTN/CTC APPLICATION FORM
1 Application Type
2 Trial Information
3 Investigational Therapeutic/Medicinal Product (excluding CTT products)
4 Investigational CTT product
5 Manufacturer Particulars
6 Comparator Therapeutic Product
7 Auxiliary Therapeutic Product
8 Local Trial Sites, PI and IRB
9 Local Sponsor (s)
10 Clinical Research Material Notification
11 Supporting Documents
12 Declaration & Confirmation
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Section 10. CRM NOTIFICATION
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Section 10. COMPANY PARTICULARS
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Section 10. PARTICULARS OF CRM
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CTM Importer/Manufacturer Endorsement
• Email to CRM importer/manufacturer contact, copied to Sponsor applicant
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CRM Importer / Manufacturer Endorsement Form
• CRM Importer / Manufacturer Rep logs in using CorpPass, can view CRM-N related fields and edit CRM importer/manufacturer contact details.
NRIC will be auto-populated from log in, and subsequently masked.
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Application Submission after Endorsement complete
• Retrieve application from Track@PRISM
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CRM-N Acknowledgement
• To CRM Importer/Manufacturer, copied to Sponsor
![Page 52: TRAINING SESSION: ENHANCED PRISM E-SERVICES · CRM NOTIFICATION FOR REGULATED TRIALS Note: •If CTA/CTN/CTC application subsequently not approved/accepted, associated CRM Notification](https://reader035.vdocuments.mx/reader035/viewer/2022071003/5fc02f646aed4812542ce8b0/html5/thumbnails/52.jpg)
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CRM NOTIFICATION FOR REGULATED TRIALS
Note:
• If CTA/CTN/CTC application subsequently not approved/accepted, associated CRM Notification will automatically expire.
• Notification will be sent to CRM importer/manufacturer (copied sponsor applicant) on expired status of CRM Notification.
• Amendment of CRM Notification is via CTA/CTN/CTC amendment application.
• CRM importer/manufacturer endorsement will be triggered for all changes to CRM Notification relevant to that particular CRM importer/manufacturer.
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THANK YOU!