training session: enhanced prism e-services · clinical trial certificate (ctc) clinical trial...
TRANSCRIPT
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TRAINING SESSION:
ENHANCED PRISM E-SERVICES
CTA/CTN/CTC APPLICATION SUBMISSION
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OUTLINE
1. Overview of CT application types for PRISM submission
2. CT application process
3. Tips for a smooth submission
4. References
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SCOPE OF TRIALS REGULATED UNDER CT REGULATIONS
REGULATED
CLINICAL
TRIALS
Clinical Trials of
Therapeutic
Products*
(e.g. pharmaceutical
drugs or biologics)
Clinical Trials of
Medicinal
Products*
(e.g. cell, tissue
and gene therapy
products, or
complementary
health products)
Health
Products
(Clinical
Trials)
Regulations
Medicines
(Clinical
Trials)
Regulations
2016
*Excluding observational trials
Clinical Trial
Authorisation
(CTA)
Clinical Trial
Notification
(CTN)
Clinical Trial
Certificate
(CTC)
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REGULATORY ROADMAP FOR TP TRIALS
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REGULATORY ROADMAP FOR MP TRIALS
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DETERMINATION OF SUBMISSION ROUTES
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CT APPLICATION FORM
• The new application form is longer to include new data set in CT Register.
• Protocol Title/ No.
• Phase
• Therapeutic Area
• Intervention [Name of Study
Drug]
• Sponsor
• Trial Site
• Principal Investigator
• Trial Status
Current Data Set in CT
Register (PRISM)NEW Data Set in CT Register
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CT 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
NEW Data Set in CT Register
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ESTIMATED TIME FOR DRAFTING ONLINE CT APPLICATION
CTA/CTN/CTC: 20-40 minutes
CTA/CTN/CTC with CRM notification: 30-45 minutes
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•
Principal
Investigator(s)
Sponsor Applicant
Manufacturer(s) /
Importer (s), if any
IRB(s)
Sponsor Applicant
HSA
Other
Sponsor(s), if
any
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
CT APPLICATION PROCESS
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eServices>Health Products Regulation>PRISM>Clinical Trials>CorpPass
login>Submit>Select Company
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Section 1. APPLICATION TYPE
Select Type of CT application type Next
Note:
1) It is recommended for applicants to fill in the application
form details in a systematic serial manner as the later
sections could reference information in the earlier
sections.
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Section 2. TRIAL INFORMATION (1 of 10)
NEW
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Note: For investigator initiated trials (IIT) involving multiple sponsors where
each site acts as a sponsor for their site, one of the sponsors should be
designated as the Lead Sponsor. The Lead Sponsor shall be the primary
contact person for HSA. Please refer to HSA Guidance on Multi-Sponsor
IIT(s).
NEW
Section 2. TRIAL INFORMATION (2 of 10)
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Click “Save” to add records
NEW
NEW
Section 2. TRIAL INFORMATION (3 of 10)
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Section 2.16:
• Treatment
• Prevention
• Diagnostic
• Supportive Care
• Screening
• Health Service
Research
• Basic Science
• Others
NEW
NEW
NEW NEW
Section 2. TRIAL INFORMATION (4 of 10)
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Section 2.21:
• Single-Blind, Double-
Blind, Open Label,
Others
Section 2.22
• Single arm, Parallel,
Cross Over, Factorial,
Others
NEW
NEW
NEW
Section 2. TRIAL INFORMATION (5 of 10)
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Note: Section 2.23- The number of study arms entered must correspond to the
number of study arms described.
NEW
Section 2. TRIAL INFORMATION (6 of 10)
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Section 2.24-2.28: Correspond to later
Sections
NEW
Section 2. TRIAL INFORMATION (7 of 10)
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Note:
1) Section 2.36- The number of trial sites must correspond to Section 8 [Local
Trial Sites, PI and IRB].
Section 2. TRIAL INFORMATION (8 of 10)
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Section 2. TRIAL INFORMATION (9 of 10)
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NEW
NEW
Section 2. TRIAL INFORMATION (10 of 10)
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Section 3. Investigational TP / MP (excluding Cell
and Tissue Therapy ) (1 of 4)
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NEW
NEW
Section 3. Investigational TP / MP (excluding Cell
and Tissue Therapy ) (2 of 4)
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Click “Save” to add records
NEW
Section 3. Investigational TP / MP (excluding Cell
and Tissue Therapy ) (3 of 4)
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Click “Save” to add records
Section 3. Investigational TP / MP (excluding Cell
and Tissue Therapy ) (4 of 4)
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Section 4. Investigational Product (Cell and Tissue
Therapy product) (1 of 5)
NEW
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Section 4. Investigational Product (Cell and Tissue
Therapy product) (2 of 5)
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Section 4. Investigational Product (Cell and Tissue
Therapy product) (3 of 5)
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Section 4. Investigational Product (Cell and Tissue
Therapy product) (4 of 5)
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Click “Save” to add records
Section 4. Investigational Product (Cell and Tissue
Therapy product) (5 of 5)
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Section 5. Manufacturer Particulars
Click “Save” to add records
NEW
NEW
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Section 6. Comparator Therapeutic Product
Section 7. Auxiliary Therapeutic ProductSection 6.
Comparator
TP
Section 7.
Auxiliary TP Fields
6.1.1 7.1.1 Comparator/Auxiliary TP
6.1.2 7.1.2 Brand/Trade Name, if any
6.1.3 7.1.3 Pharmacological Class
6.2.1 7.2.1 Dosage Form
6.2.2 7.2.2 Route of Administration
6.2.3 7.2.3 Strength
6.2.4 7.2.4 Category of Investigational TP
6.2.5 7.2.5 Marketing Authorisation Status in other
countries
6.2.6 7.2.6 Product Registration Number (if applicable)
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Section 8. Local Trial Sites, PI and IRB (1 of 2)
The PI will
receive
endorsement
email via the
primary email
address.
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Click “Save” to add records
NEW
Section 8. Local Trial Sites, PI and IRB (2 of 2)
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Section 9. Local Sponsor (s) (1 of 3)
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Other Sponsor(s) Contact Person
will receive endorsement email via
the primary email address
Section 9. Local Sponsor (s) (2 of 3)
NEW
Note: For multi-sponsors clinical trial indicated in Section 2, particulars of Other
Sponsor(s) are required in Section 9.3.
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Click “Save” to add records
Note: Section 9.5.1-9.5.9 will be editable from the
endorsement form.
Section 9. Local Sponsor (s) (3 of 3)
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Clinical Trial Certificate
(CTC)
Clinical Trial Authorisation
(CTA)
Clinical Trial Notification
(CTN)
Submission Dossier
• Protocol
• Informed Consent Form
• Investigator’s Brochure
• Principal Investigator’s CV
• GMP Certificate
• COA
• CMC documents, if requested
• Protocol
• Informed Consent Form
• Approved Product Label
• IRB approval letter
Section 11. Supporting Documents
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Section 12. Declaration and Confirmation (1 of 2)
Note: Upon clicking “Notify”, endorsement emails, will be sent to PI(s), Other Sponsor (s), CRM
importers [if applicable].
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Section 12. Declaration and Confirmation (2 of 2)
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•
Principal
Investigator(s)
Sponsor Applicant
Manufacturer(s) /
Importer (s), if any
IRB(s)
Sponsor Applicant
HSA
Other
Sponsor(s), if
any
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
CTA/CTN/CTC APPLICATION PROCESS
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Note: Endorsement emails (copied sponsor applicant), will be sent to the PI(s), Other
Sponsor(s) and CRM Importer(s) [if applicable].
Endorsement Email(s)
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NRIC/FIN of PI will be auto-
populated from his/her login; and
would be masked from the
applicant subsequently.
PI Endorsement (1 of 2)
• PI logs in using CorpPass to retrieve and view drafted application form; and edit particulars of Principal Investigator [Section 8.4-8.10].
Name of PI
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PI Endorsement (2 of 2)
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Other Sponsor(s) Endorsement (1 of 2)
NRIC/FIN of Endorser will be auto-
populated from his/her login
• Other Sponsor Endorser logs in using CorpPass to retrieve and view drafted application form; and edit particulars of Other Sponsor Contact Details (Endorser)[Section 9.5.1-9.5.9]
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Other Sponsor(s) Endorsement (2 of 2)
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Endorsement(s) Complete• Once endorsement(s) from relevant parties are completed, the sponsor/lead sponsor
will receive an email notification to proceed with submission
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•
Principal
Investigator(s)
Sponsor Applicant
Manufacturer(s) /
Importer (s), if any
IRB(s)
Sponsor Applicant
HSA
Other
Sponsor(s), if
any
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
CTA/CTN/CTC APPLICATION PROCESS
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Check Endorsement via TRACK@PRISM
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Submission Declaration
Lead Sponsor Declaration for
multi-sponsor IIT(s)
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Submission Complete
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ESTIMATED TIME FOR DRAFTING ONLINE CT APPLICATION
CTA/CTN/CTC: 20-40 minutes
CTA/CTN/CTC with CRM notification: 30-45 minutes
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TIPS FOR A SMOOTH ONLINE SUBMISSIONBefore drafting CT application…
1. Determine application type before drafting [Refer
CTA/CTN/CTC Determination Guidance Nov 2016]
2. Determine the number of site(s), PI(s), Other
Sponsor(s)
3. Prepare trial information [Study Design, No. of
Investigational TP/MP, comparator TP/MP, auxiliary
TP/MP, Investigational CTT(s), manufacturer details
etc.]
4. Prepare CRM importer(s) information, if applicable
5. Prepare supporting documents [Protocol, ICF(s),
Product label/IB, CoA, GMP etc.]
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REFERENCES
I. Health Products (Clinical Trials) Regulations
II. Medicines (Clinical Trials) Regulations
III. Guidance on determination of whether a clinical
trial requires a CTA, CTN or CTC [GN-CTB-2-
001A-001]
IV. Guidance on regulatory requirements for new
applications and subsequent submissions [GN-
CTB-2-003A-001]
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THANK YOU!