Pharmaceutical Regulatory Information System
(PRISM)
Internet – Clinical Trial Certificate Module
User Manual
Ver 1.1 (20 August 2003)
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PRISM
User Manual For Internet – Clinical Trial Certificate
Ver 1.1 (20 August 03)
REVISION HISTORY
Version
Summary of Changes
Author
1.0
Effective
Date
30 June 03
First Release
1.1
20 Aug 03
1. Change in the Screen Capture for Prism@hsa
2. Centralize header : GUIDE TO APPLICATION
FOR CLINICAL TRIAL CERTIFICATE
NCS PRISM Team
and HSA-CTU
NCS PRISM Team
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User Manual For Internet – Clinical Trial Certificate
Ver 1.1 (20 August 03)
Table of Contents
1.
INTRODUCTION ................................................................................................................................... 4
PURPOSE .................................................................................................................................................... 5
SCOPE ........................................................................................................................................................ 5
OVERVIEW ................................................................................................................................................... 5
Overview of the Electronic Application Process for CTC................................................................ 6
2.
FUNCTIONS .......................................................................................................................................... 7
2.1
TO APPLY FOR NEW CLINICAL TRIAL CERTIFICATE ESERVICE .............................................................. 7
2.2
COMMON ICONS AND NAVIGATION LINKS .......................................................................................... 10
2.3
APPLICATION FORM OF CLINICAL TRIAL CERTIFICATE ESERVICE........................................................ 11
2.3.1
Trial Information .................................................................................................................. 11
2.3.2
Study Drugs to be investigated ......................................................................................... 16
2.3.3
Comparator Drugs to be used............................................................................................ 19
2.3.4
Concomitant Drugs to be used .......................................................................................... 21
2.3.5
Local Trial Centres, PI and IRB .......................................................................................... 23
2.3.6
Local Contract Research Organisation ............................................................................ 26
2.3.7
Information on Sponsor (Local and Overseas) ................................................................ 28
2.3.8
Supporting Attachments .................................................................................................... 29
2.3.9
Declaration & Confirmation ................................................................................................ 30
2.3.10 Acknowledgment ................................................................................................................. 37
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User Manual For Internet – Clinical Trial Certificate
1.
Ver 1.1 (20 August 03)
Introduction
There are two parts (Part 1 and Part 2) to this document. Part 1 is a 1-page document that outlines the
guideline on the application for Clinical Trial Certificate (CTC). Part 2 is a detailed instruction manual to
assist the user in using the system effectively.
PART 1
REPUBLIC OF SINGAPORE
HEALTH SCIENCES AUTHORITY
THE MEDICINES ACT 1975
THE MEDICINES (CLINICAL TRIALS) REGULATIONS 1978
THE MEDICINES (CLINICAL TRIALS) (AMENDMENT) REGULATIONS 1998
GUIDE TO APPLICATION FOR CLINICAL TRIAL CERTIFICATE
(a) Clinical Trials are defined as any investigation in human subjects intended to discover or verify the clinical,
pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify
any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism,
and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The
terms clinical trial and clinical study are synonymous.
(b) Before any clinical trials on medicinal product(s) can be conducted, a certificate to conduct the clinical trial
issued by the Health Sciences Authority is required.
(c) Conduct of clinical trials in Singapore is regulated by the Medicines Act 1975 and the Medicines (Clinical
Trials) (Amendment) Regulations 1998. In addition, the Singapore Guide for Good Clinical Practice (SGGCP) has to be observed in the conduct of local clinical trials.
(d) Clinical Trial Certificates (CTCs) issued are specific to the study drug, the trial protocol and the trial centre.
Each trial centre involved in the multicentre trial will have its own CTC.
(e) Only one application is required to be made for clinical trials on the same drug using the same trial protocol
regardless of the number of trial centres.
(f)
CTCs are issued in the name of the principal investigator and each CTC is valid for a period of two years
unless otherwise stated.
(g) If a trial is not completed upon the expiry of the CTC, the sponsor has to make a written request for an
extension of the CTC and submit an interim clinical trial status report to support the request.
(h) The supporting documents for the trial could be submitted as electronic copy attachments. For the list of
supporting documents see Section 2.3.8 on Supporting Attachments of this manual. Please note that for
the supporting document of GMP Certificate, it should be issued by the relevant regulatory authority in the
country of the manufacturer and should state that the facilities and operations of the manufacturer(s)
conform to Good Manufacturing Practice (GMP) as recommended by the World Health Organisation (WHO)
or other equivalent standards. For medicinal products that have been registered with the Health Sciences
Authority, GMP certificates need not be submitted. Certificates of Analysis (CoA) for the batches of study
drug(s) and any comparator(s) and placebo used in the study should be attached in the application if the
GMP Certificate(s) is not available. If the CoA are not available at the time of application to HSA, they should
be submitted when available. Note that CoA for any further batches used in the study should also be
submitted to HSA.
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User Manual For Internet – Clinical Trial Certificate
Ver 1.1 (20 August 03)
PART 2
Purpose
The purpose of this user manual is to ensure that all nominated application users will be proficient in
the use of the online application system.
Scope
The scope of the manual is to provide information on the use of PRISM 1b eService for the online
application for Clinical Trial Certificate(s) (Internet).
Overview
This document provides brief details on the standards and guidelines that a user should adhere to in
doing an online preparation and submission of an application. It divides the application procedure
into sections and provides the brief guidelines for each of them.
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Ver 1.1 (20 August 03)
Overview of the Electronic Application Process for CTC
Access CTC application form at HSA homepage. Under [Business &
Service Access] link, select [One-Stop e-Services]  [prism@hsa] 
[Apply for CTC]
Complete the form and attach supporting documents such as protocol,
patient informed consent form, etc.
The last section of the form “Declaration & Confirmation” would display
all the information the applicant has entered. After verifying the
information, the applicant can proceed with the system validation by
clicking on the “Validate” button. If there are missing information, which
do not meet the application requirements, a separate pop-up screen will
appear with details of the validation error.
(Applicant)
Sponsor
Upon successful validation of the form, the applicant would have to
notify the PI(s), IRB representative of each site, and witness of the
sponsor. The applicant can click on the “Notify” button to activate the
process.
Notify
Note that once the notification process is activated, the application form
cannot be modified anymore. In the event that there is an error in the
form, a new application form has to be used and the process repeated
(i.e. a new online transaction is created). However, the applicant can
use the “Copy-to-Draft” function to copy information over to the new
application and make the appropriate amendments.
The notification process is by e-mail to these 3 parties. In order to
ensure the authenticity of these parties, the correct NRIC No. (i.e.
their SingPass ID* to login to the system with read only access to
the application information) and e-mail addresses of these persons
have to be indicated in the application form.
PI
IRB
PI & IRB of
each site have
to be notified
Accept
Witness
(Sponsor)
* For Singaporeans, it will be their NRIC No.
For Non-Singaporeans, it will be their CPF Account No./FIN No.
For more information on SingPass, please visit the CPF website at
www.cpf.gov.sg/cpf_trans/palpin_faq.asp
Each PI will receive an e-mail notifying him/her to endorse the
application online. The e-mail message will contain an URL hyperlink to
the completed application form in the system. By clicking on the URL
hyperlink, the PI would be able to view the CTC application. After
reviewing, the PI can then accept the application. By clicking on the
“Accept” button and submitting to the sponsor, the PI confirms his/her
participation and certifies his/her duties in the application form. This
electronic authentication process is equivalent to having the PI
physically signing on the CTC application form.
Each IRB representative will similarly be able to have read only access
to the application information. The e is no need for the IRB to respond
to the sponsor. The completed e-CTC application form is sent to them
for information only.
(Applicant)
Sponsor
The witness will have to verify the completed application form. By
clicking on the “Accept” button and submitting back to the applicant, the
witness is certifying the accuracy of the application information.
After all the PI(s) and witness have certified the application information
by clicking on the “Accept” button, the applicant would be notified by email. The applicant would then be able to submit the CTC application
form with the trial document attachments to HSA electronically.
Submit
HSA
After submitting to HSA, applicants would receive an e-notification of the
application number. There will be an option for the applicant to print the
completed application form that has been submitted in a printer friendly
version.
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Ver 1.1 (20 August 03)
2. Functions
2.1
To Apply for New Clinical Trial Certificate eService
Steps :
Click on the following :
- E-SERVICES (Needs to be amended with the new screen shots)
- prism@hsa
- Apply For New Clinical Trial Certificate
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2.1.1
Ver 1.1 (20 August 03)
Login
Fill in your SingPass ID and click the Submit button.
In the next screen, fill in your password and click on the Login button.
The predefined roles of the users, comprising of drafter, submitter, CRIS administrator, counter
staff, will be verified against the CRIS authorisation.
Upon successful authentication, a page will be shown for the applicant to choose to apply as an
Individual / Director or for a specific company.
Select the specific company and click the Submit button.
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The Terms and Conditions page will be shown. The application user is required to read the Terms
and Conditions before indicating accept or reject. If the Accept button is clicked, the user will be able to
proceed with the eService. If the Cancel button is clicked, the page will be re-directed to the HSA
homepage.
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2.2
Ver 1.1 (20 August 03)
Common Icons and Navigation Links
Common icons and links in all sections :
Attach icon. This will allow user to go to the Supporting Attachments page to attach
relevant documents.
Save icon. This will allow the user to save the form information at any desired point of time.
Application form links. This will allow the user to toggle to different sections of the
application form.
This will allow the user to proceed to the next section of the application form.
Previous button. This will allow the user to proceed to the previous section of the
application form.
Reset button. This will clear the information the user has input in the page.
Fields with a red asterix * are mandatory input fields. Unless it is entered, the system
validation will highlight error and application submission will be disabled.
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2.3
Ver 1.1 (20 August 03)
Application Form of Clinical Trial Certificate eService
The application form consists of 9 sections:
1
2
3
4
5
6
7
8
9
Trial Information
Study Drugs to be investigated
Comparator Drugs to be used
Concomitant Products to be used
Local Trials Centres, PI and IRB
Local Contract Research Organisation
Sponsor (Local and Overseas)
Supporting Attachments
Declaration & Confirmation
It is recommended for users to fill in the application form details in a systematic serial manner as the later
sections could reference information in the earlier sections.
2.3.1
Trial Information
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User Manual For Internet – Clinical Trial Certificate
Ver 1.1 (20 August 03)
This section caters for the input of the clinical trial information and design. Brief notes on completing
some of the sections are provided below:
(a) Section 1.3: Indicate the phase of the study. For a Phase 1 study, the user has to indicate whether it
is a “First-In-Man” study. For studies that have trial type as a combination of two phases e.g. Phase
I/II or Phase II/III type of studies, please indicate the trial type as Phase 1 or Phase 2, respectively.
The user can have the option to provide a brief description of the trial type in the free text box under
this sub-section. Note that the free text box is enabled only when the “Not Applicable” box is not
checked. If a study does not fall in any of the phase type for e.g. bioequivalence or compassionate
studies, indicate the type of study as “Others”. The user would have to provide a brief description in
the text area next to “Others”.
(b) Section 1.5: Select from the Drop Down List (DDL) the appropriate therapeutic area or the type of
medical condition that is under investigation in the study. Most Phase I studies would fall under the
area of Human Pharmacology (in the DDL). If Others (in the DDL) is selected, the user has to provide
a brief description of the medical condition.
(c) Section 1.7: List any previous application(s) for trials involving the same study drug. Indicate the CPA
reference number e.g. “CPA(PER) 78:10/02-001” Otherwise, please check the “Not Applicable” box.
Please note that this is also a sub-record section. Hence after the entry of each application number,
the user has to click on the “Save” button to save the record. If this is not done, the information in this
subsection will not be saved.
To add a previous HSA Clinical Trial Certificate Application Number
1) Fill in the Clinical Trial Certificate Application Number.
2) Click on the Save button.
3) To add another Clinical Trial Certificate Application Number, Click on the New button to
refresh the page.
4) Repeat steps (1) to (2) again, to continue adding a new record.
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Ver 1.1 (20 August 03)
To remove HSA Clinical Trial Certificate Application Number
1) Click on the checkbox beside the application number(s) from the List of HSA Clinical Trial
Certificate Application Number.
2) Click on the Remove button to delete the application number(s).
To amend the information on the HSA Clinical Trial Certificate Application Number
Click on the required application number from the List of HSA Clinical Trial Certificate
Application Numbers.
Make the required changes.
Click on the Save button.
(d) Section 1.11: Multiple check boxes indicating “Placebo”, “Comparator Drug” and “Concomitant Drug”
can be selected here. If the study does not use any of these 3 types of products, the user can check
the “Not Applicable” box. Concomitant drugs are required as part of the treatment regimen. Hence
they are specified in the protocol and are commonly used for e.g. in oncology or HIV studies. Note
that if the check box for “Comparator Drug” and/or “Concomitant Drug” is not selected, the field(s) in
next sections 1.13 and/or 1.14 as well as in sections 3 and/or 4 would not be enabled for entry.
(e) Section 1.12: The number of study drug(s) indicated here would determine the entry of information in
section 1.15 and section 2. For e.g. if the no. of study drug used is indicated as 2, the user has to
provide the information for the 2 study drugs in sections 1.15 and 2.
(f) Sections 1.13 and 1.14: The number of comparator / concomitant drug(s) indicated in these sections
would determine sections 3 and 4. For e.g. if the no. of comparator drug used is indicated as 1, the
user can only provide the information for only 1 comparator drug in section 3. See also description
under (d) for section 1.11.
(g) Section 1.15: Enter the study drug name and choose one of the study drug administration schedules
and duration.
Single dose is defined as a single dosing of the study drug given once only for the duration of the
study.
–
If Single Dose is selected, there is no need to complete duration of study drug dosing.
Multiple dose is defined as continuous study drug administration without any interruption.
Cyclical dose is defined as an intermittent or cyclical administration of the study drug during the
treatment period specified in the protocol. For e.g. study drug administration is given between
periods of interval or in oncology studies where the study drug is administered over a period of
time (e.g. 3 hours) once every 3 weeks.
–
If Multiple/Cyclical Dose is selected, please select one of the options provided under duration
of study drug dosing/treatment. Any supplemental information can be detailed in section 1.17.
The user can choose “Others” if the study drug administration schedule doesn’t meet any of the
above definitions and elaborate in section 1. 7.
Please note that this is also a sub-record section. Hence after the entry for the information of each
study drug, the user has to click on the “Save” button to save the record. If this is not done, the
information in this subsection will not be saved,
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Ver 1.1 (20 August 03)
To add Study Drug
Fill in the Study Drug Name.
Fill in the study drug administration schedule and duration.
Click on the Save button.
To add another Study Drug, Click on the New button to refresh the page.
Repeat steps (1) to (3) again, to continue adding a new record if there is more than one study
drug indicated in section 1.12.
To remove Study Drug
1) Click on the checkbox beside the study drug(s) from the List of Study Drug(s)
2) Click on the Remove button to delete the study drug (s).
To amend the information on the Study Drug
Click on the required study drug name from the List of Study Drug(s)
Make the required changes.
Click on the Save button.
(h) Enter any supplemental information on the trial design in Section 1.17. Otherwise, please check the
“Not Applicable” box.
(i) Section 1.19: Note that the number of trial centres indicated here would determine the entry of
information in section 5. For e.g. if the no. of trial centres is indicated as 2, the user has to provide the
information for the 2 trial centres in section 5. In this case a third trial centre cannot be added in
section 5 unless the information in section 1.19 is amended accordingly.
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2.3.2
Ver 1.1 (20 August 03)
Study Drugs to be investigated
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Ver 1.1 (20 August 03)
This section caters for the input of Study Drug(s) information
1) Click on the study drug name hyperlink at the bottom of the page.
2) Fill in the Study Drug details.
3) In section 2.8, select the appropriate Anatomical Therapeutic Classification (ATC) for the study drug
from the Drop Down List. Note that this is a 2 level selection. For the description of these 2 levels of
selection according to the ATC, please see the information on the next page.
4) Please provide the product licence number in Section 2.11 if the investigational product(s) used is
registered in Singapore. Product licence number can be obtained from the HSA - CPA website.
Otherwise, please tick the “Not Applicable” box.
5) Fill in details of the Manufacturer of Active Ingredient in Section 2.12 - 2.22.
6) Select the address type - local or overseas. For local addresses, enter the postal code and click on
the “Retrieve” button. Subsequently, only the level and the unit number have to be entered.
7) Click on the Save button.
8) To fill in Study Drug details for other Study Drugs, Click on the required study drug name from the
List of Study Drug(s).
9) Repeat Steps (1) to (5) again.
10) Click Next button to go to the Comparator Drug to be used section.
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Anatomical Therapeutic Classification (ATC) Description (2 levels)
Alimentary tract and metabolism *
Other hematological agents
Nervous system *
Stomatological preparations **
Cardiovascular system *
Anesthetics **
Drugs for acid related disorders
Drugs for functional gastrointestinal
disorders
Cardiac therapy **
Analgesics
Anithypertensives
Antiepileptics
Diuretics
Anti-Parkinson drugs
Antiemetics and antinauseants
Peripheral vasodilators
Bile and liver therapy
Laxatives
Antidiarrheals, intestinal
antiinflammatory/antiinfective agents
Antiobesity preparations, excl. diet
products
Vasoprotectives
Beta blocking agents
Calcium channel blocke s
Agents acting on the renin-angiotensin
system
Psycholeptics
Psychoanaleptics
Other nervous system drugs
Respiratory system *
Nasal preparations **
Digestives, incl. Enzymes
Serum lipid reducing agents
Throat preparations
Drugs used in diabetes
Dermatologicals *
Drugs for obstructive airway diseases
Vitamins
Antifungals for dermatological use **
Cough and cold preparations
Mineral supplements
Emollients and protectives
Preparations for treatment of wounds
and ulcers
Antipruritics, incl. antihistamines,
anesthetics, etc
Antihistamines for systemic use
Tonics
Anabolic agents for systemic use
Apetite stimulants
Other alimentary tract and metabolism
products
Antiinfectives for systemic use *
Antibacterials for systemic use **
Antimycotics for systemic use
Antivirals for systemic use
Immune sera and immunoglobulins
Vaccines
Antineoplastic and
immunomodulating agents *
Antineoplastic agents **
Immunostimulants
Immunosuppressive agents
Antiparasitic products,insecticides
and repellents *
Anthelmintics
Ectoparasiticides,incl.scabicides,
insecticides and repellents
Blood and
blood forming organs *
Antithrombotic agents **
Anti-acne preparations
Corticosteroids for systemic use
Other dermatological preparations
Genito urinary system and sex
hormones *
Gynecological antiinfectives and
antiseptics **
Thyroid therapy
Pancreatic hormones
Calcium homeostasis
Various *
Allergens **
All other therapeutic products
Urologicals
Diagnostic agents
Musculo-skeletal system *
Antiinflammatory and antirheumatic
products **
Topical products for joint and muscular
pain
General nutritients
Muscle relaxants
Therapeutic radiopharmaceuticals
Antigout preparations
Surgical dressings
Drugs for treatment of bone diseases
Antihemorrhagics
Antianemic preparations
Blood substitutes and perfusion
solutions
Ophthalmologicals **
Medicated dressings
Other gynecologicals
Sex hormones and modulators of the
genital system
Endocrine therapy
Sensory organs *
Otologicals
Ophthalmological and otological
preparations
Systemic hormonal preparations,
excl. sex hormones and insulins **
Pituitary, hypothalamic hormones and
analogues **
Antiseptics and disinfectants
Antimycobacterials
Antiprotozoals **
Antipsoriatics
Antibiotics and chemotherapeutics for
dermatological use
Corticosteroids, dermatological
preparations
Other respiratory system products
Other drugs for disorders of the
musculo-skeletal system
All other non-therapeutic products
Contrast media
Diagnostic radiopharmaceuticals
* 1st level selection
** 2nd level selection
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2.3.3
Ver 1.1 (20 August 03)
Comparator Drugs to be used
This section caters for the input of Comparator drug(s) information.
To add Comparator Drug
1) Fill in the Comparator Drug details.
2) Please provide the product licence number in Section 3.10 if the comparator(s) used is registered in
Singapore. Product licence number can be obtained from the HSA - CPA website. Otherwise, please
tick the “Not Applicable” box.
3) Click on the Save button.
4) To add another Comparator Drug, Click on the New button to refresh the page.
5) Repeat steps (1) to (3) again.
6) Click Next button to go to the Concomitant Drug to be used section.
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Ver 1.1 (20 August 03)
To remove Comparator Drug
Click on the checkbox beside the comparator drug(s) from the List of Comparator Drug Name(s).
Click on the Remove button to delete the comparator drug(s).
To update Comparator Drug
Click on the required application number from the List of Comparator Drug Name(s).
Make the required changes.
Click on the Save button.
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2.3.4
Ver 1.1 (20 August 03)
Concomitant Drugs to be used
This section caters for the input of Concomitant Drug(s) information.
To add Concomitant Drug
Fill in the Concomitant Drug details.
Please provide the product licence number in Section 4.10 if the concomitant drug(s) used is
registered in Singapore. Product licence number can be obtained from the HSA - CPA website.
Otherwise, please tick the “Not Applicable” box.
Click on the Save button.
To add another Concomitant Drug, Click on the New button to refresh the page.
Repeat steps (1) to (3) again.
Click Next button to go to the Local Trial Centres, PI and IRB section.
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Ver 1.1 (20 August 03)
To remove Concomitant Drug
Click on the checkbox beside the Concomitant drug(s) from the List of Concomitant Drug
Name(s) table.
Click on the Remove button to delete the Concomitant drug(s).
To update Comparator Drug
1) Click on the required application number from the List of Concomitant Drug Name(s) table.
2) Make the required changes.
3) Click on the Save button.
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Ver 1.1 (20 August 03)
Local Trial Centres, PI and IRB
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This section caters for the input of the Local Trial Centres, PI and IRB information.
To add a Local Trial Centre
1) Select the trial centre from the Drop Down List.
2) If the trial centre is not listed, please choose “Others” and specify it in Sect on 5.2.1.
3) For Address of Practice, fill in the postal code and click on the Retrieve Address button.
4) Fill in Level-Unit information if applicable.
5) Fill in the other details required.
In order to ensure the authenticity of the PI(s) and IRB representative(s), the correct NRIC No. (i.e.
their SingPass ID to login to the system) and e-mail addresses of these persons have to be indicated
in this section. See also the information on the overview flow chart on page 6.
6) Indicate if the Address of Trial Centre is different from the Address of Practice by choosing the
relevant radio button in Section 5.11.
7) If the Address of Trial Centre is different from the Address of Trial Centre, fill in the Address of
Trial Centre postal code and click on the Retrieve Address button.
8) Fill in Level-Unit information if applicable.
9) Fill in the Address of IRB in section 5.15.
10) Fill in the postal code and click on the Retrieve Address button.
11) Fill in Level-Unit information if applicable.
12) Fill in the other IRB details. See point no. 5).
13) Click on the Save button.
14) To add another Local Trial Centre, Click on the New button to refresh the page.
15) Repeat steps (1) to (13) again.
16) Click Next button to go to the Local Contract Research Organisation section.
To remove Local Trial Centre
1) Click on the checkbox beside the trial center name(s) from the List of Trial Centre Name(s).
2) Click on the Remove button to delete the trial center name(s).
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Ver 1.1 (20 August 03)
To update Local Trial Centre
1) Click on the required application number from the List of Trial Centre Name(s).
2) Make the required changes.
3) Click on the Save button.
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2.3.6
Ver 1.1 (20 August 03)
Local Contract Research Organisation
This section caters for the input of information on Local Contract Research Organization (CRO).
Indicate if any part of the Clinical Trial is to be conducted by a Local Contract Research
Organization (CRO) in Section 6.1.
If Yes, details of the Local CRO have to be provided.
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To add a Local CRO
Fill in the Company Name.
Fill in the Postal Code.
Click on the Retrieve Address to get the address.
Fill in Level-Unit information if applicable.
Fill in other details and also indicate in Section 6.3.4 if the local CRO is also the local sponsor for
the clinical trial.
Click on the Save button.
To add another Local CRO, Click on the New button to refresh the page.
Repeat steps (1) to (6) again.
Click Next button to go to the Sponsors (Local and Overseas) section.
To remove Local CRO
1) Click on the checkbox beside the local CRO company name(s) from the List of Local CRO
Company Name(s) table.
2) Click on the Remove button to delete the local CRO(s).
To update Local CRO
1) Click on the required local CRO company name from the List of Local CRO Company Name(s)
table.
2) Make the required changes.
3) Click on the Save button.
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Ver 1.1 (20 August 03)
Information on Sponsor (Local and Overseas)
This section caters for the input of information of Sponsor (Local and Overseas).
1)
2)
3)
4)
5)
6)
Fill in the Company Name for Local Sponsor.
Fill in the Postal Code.
Click on the Retrieve Address to get the address.
Fill in Level-Unit information if applicable.
Fill in the Name of Witness.
Fill in the other details of the Witness. It is important that you enter an accurate email address as an
email will be sent to the specified address for the witness to accept/ reject the CTC application.
7) Indicate an Overseas Sponsor is applicable.
8) If Applicable, Fill in the Overseas Sponsor Company Name.
9) Click Next button to go to the Supporting Attachments section.
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Supporting Attachments
GMP Certificate(s) should be issued by the
relevant regulatory authority in the country of the
manufacturer and should state that the facilities
and operations of the manufacturer(s) conform to
Good Manufacturing Practice (GMP) as
recommended by the World Health Organisation
(WHO) or other equivalent standards.
For medicinal products that have been registered
with the Health Sciences Authority, GMP
certificates need not be submitted.
Certificates of Analysis (CoA) for the batches of
study drug(s) and any comparator(s) and placebo
used in the study should be attached in the
application if the GMP Certificate(s) is not
available for the respective type of products.
If the CoA are not available at the time of
application to HSA, they should be submitted
when available.
Note that CoA for any further batches used in the
study should also be submitted to HSA.
This section allows the attachment of the supporting documents for the application.
Add Attachment
Click on the Browse button to select the required file for attachment.
Select the required file.
Click on the Ok button.
Click on the Attach File button for the file to be attached to this application.
Fill up remarks with regards to the attachment if required.
Remove Attachment
1) Click on the checkbox beside the attachment or attachments from the List of Attachments table.
2) To delete all attachments, click on the checkbox beside S/n.
3) Click on the Remove button.
The file extensions, whic
tif
jpg
pdf
doc
are acceptable and supported, are:
xls
ppt
avi (audio visual, if required)
mpeg(audio visual, if required)
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User Manual For Internet – Clinical Trial Certificate
2.3.9
Ver 1.1 (20 August 03)
Declaration & Confirmation
This section shows all the information the user has entered into the different sections of the application
form. It allows the user to manually verify all the information fields.
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To proceed with the system verification the information on the application form,
1) Click on the Verify button.
2) If there are any missing mandatory information or details, which do not meet the application
requirements, a pop up screen will appear with the details of the validation error.
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This will allow the user to take note of the relevant changes to be made and return back to the application
form and amend accordingly.
Notify
The applicant would need to click on the Notify button to inform the PI, IRB and Witness of the
application of Clinical Trial Certificate. The PI and Witness would need to indicate whether they support
the application. The applicant will be informed of their decision. If both parties accept the application, the
applicant can proceed to accept the declaration and submit the application to the Clinical Trials Unit of the
Centre of Pharmaceutical Administration. If either party declines the application, the applicant would need
to draft a new application again.
The IRB will have read-only access to the application information. There is no need for the IRB to
respond to the sponsor. The completed e-CTC application form is sent to them for information only.
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Declaration
The user has to read the declaration text in this section and indicate the decision. If the user accepts the
declaration, the Accept radio button has to be chosen in order for the application to proceed for
submission. If the user declines the declaration, the application cannot proceed for submission.
2.3.10 Acknowledgment
This section acknowledges that the application has been submitted to HSA for processing. An Application
number will be generated for the application.
Links
Show Printer Friendly version
This allows the applicant to print or view the application.
New Application For A Clinical Trial Certificate
This allows the applicant to submit a new application for a Clinical Trial Certificate without repeating
the authentication and authorisation process.
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