Clinical Trial Applications in eCTD format

This document is a subset of information on how to file clinical trial applications and related information
in eCTD format

Health Canada intends to update the Guidance Document: Preparation of Regulatory Activities in eCTD
Format in the future to include information for clinical trial regulatory activities.

1. Regulatory Activity (RA) types and Regulatory Transactions (RTs) that are in scope of the Clinical Trial
Application dossier in eCTD format.

 Pre-Clinical Trial Application Consultation Meeting (Pre-CTA)

 Clinical Trial Application (CTA) with either a 7 day administrative or a 30 day default
performance standard
 Clinical Trial Applications - Amendments (CTA-A) with a 7 day administrative or a 30 day default
performance standard
 Clinical Trial Application - Notification (CTA-N)
 All related responses and post-clearance data to the regulatory activities above
 Investigational Status Assessment (ISA)

2. Regulatory Activity (RA) types and Regulatory Transactions (RTs) that are out of scope of the Clinical
Trial Application dossier in eCTD format.

 Clinical Trial Site Information (CTSI) (Reference #39)

 Development Safety Update Report (DSUR) (Reference #38)
 Signal assessment related requests from the Therapeutic Products Directorate/Office of Clinical
Trials – Adverse Drug Reaction division (OCT ADR) (Reference #37)
 Fax-Backs for the Biologics and Genetic Therapies Directorate
 Adverse Reaction Reports provided to MHPD (Reference #36)

3. Information on filing clinical trials in eCTD format to Health Canada, for the first time.

Refer to sections 4.1 to 4.5 of the Guidance Document: Preparation of Regulatory Activities in eCTD
Format for information on:
 How to file a sample in eCTD format
 Pre-submission technical meetings
 Requesting a dossier ID

4. Requesting a dossier ID for filing clinical trials in eCTD format.

Prior to filing the first regulatory transaction for a dossier in eCTD format, the sponsor must request
a dossier ID using the on line dossier ID request form.

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5. Transmitting Clinical Trials regulatory transactions in eCTD format.

All eCTD transactions must be sent to Health Canada using the common electronic submissions
gateway (CESG). Refer to section 3.2 of the Guidance Document: Preparation of Regulatory Activities
in eCTD Format and the CESG related Frequently Asked Questions document.

6. Placement of module 1 documents for clinical trial dossiers.

For placement of all documents in module 1, refer to the Organisation and Document Placement for
Canadian Module 1 of the CTD Structure available on the Filing Submissions Electronically
information page.

7. Product Monograph in Module 1.

The Product Monograph must be placed in section “1.3.1 Product Monograph” of the eCTD
structure.

8. CTAs and existing “NDS” eCTD dossiers identifiers.

The CTA and the related regulatory activities and transactions should not be submitted using the
existing “NDS” eCTD dossier ID.

A Dossier:
 For clinical trials, it is a collection of all regulatory activities throughout the life cycle of a single
clinical trial protocol.
 For Pharmaceutical/Biological products, it is a collection of all regulatory activities throughout
the life cycle of a product(s).

9. eCTD identifiers and Brand Name (common name).

The eCTD dossier IDs for Clinical trial applications are created based on protocol number, they are
not product based.

10. Information on cross-referencing the Chemistry and Manufacturing (CMC) and the Investigator's
Brochure (IB) to the previously filed and approved CTA.

In the proposed eCTD CTA it is acceptable to cross-reference CMC data to the previously filed and
approved CTA in non-eCTD electronic-only format. A note to reviewer should be created and placed
in section 1.0.7 “Note to Reviewer”. The cover letter should not be used for this purpose.

The IB cannot be cross referenced and has to be provided (when applicable) in every CTA regulatory
activity.

11. Providing the same (previously approved) data/information again across the dossiers even though
the cross referencing applies.

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 The already approved information can be re-provided again in different/other CTA dossier(s) for the
completeness of the dossier. However, sponsors have to be explicit, by attesting:
 what information was previously reviewed and approved versus the new information;
 under which regulatory activity, control number and dossier ID.

This is to avoid Health Canada from duplicating screening and review processes and when latest
regulatory transaction is received.

12. Filing a CTA-A or CTA-N as the first transaction (sequence 0000) in eCTD format.

A CTA-A or CTA-N can be filed in eCTD as the first eCTD transaction (sequence 0000) as per the
below outlined timelines:
 a CTA-A, with a 7 day administrative or a 30 day default performance standard, in eCTD
format where the initial CTA has been filed after June 30, 2016;
 a CTA Notification, where the initial CTA has been filed after June 30, 2016.

For the full scope of filing clinical trial regulatory activities in eCTD format, refer to the eCTD clinical
trials notice available on the Filing Submissions Electronically page.

Reminder: Please note that each CTA-A and or CTA-N must be filed individually for each affected
protocol. A separate dossier ID must be requested based on protocol.

13. Using the same cover letter when filing CTA-A or CTA-N to multiple protocols for a same product.

The same cover letter can be used listing the dossier IDs and protocol numbers of each protocol to
which the CTA-A or CTA-N applies.

Reminder: please note that each CTA-A and or CTN must be filed individually for each affected
protocol.

14. Filing pre-submission meeting request/package covering multiple clinical trial dossiers.

It is not acceptable to file one pre-CTA meeting request/package for multiple clinical trial dossiers.
The same pre-submission request/package can be used, however it must be submitted separately
for each protocol based dossier it applies to.

Note: The same cover letter can be used listing the dossier IDs and protocol numbers of each
protocol to which the pre-CTA meeting request/package applies.

15. Format of the Informed Consent Form (ICF).

ICFs can be provided in Word and PDF formats. The PDF file should be created from the original
electronic source with no document restrictions. Scanned copies are not acceptable.

16. File format of the Protocol Safety and Efficacy Assessment Template - Clinical Trial Application
(PSEAT-CTA) and Quality Overall Summary (QOS) documents.

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 As per the “Non-eCTD Electronic-Only” guidance document, the PSEAT-CTA and QOS for CTAs should
only be submitted in Word format.

17. How lifecycles are handled when additional arms are added to a clinical trial involving other
investigational products, which themselves have their own lifecycle such as:
 treatment arm for each histology sub-type;
 multiple investigational product trials;
 combination of investigational products; and
 additional investigational products.

The eCTD dossier IDs for Clinical trial applications are created based on protocol number. Dossiers
for clinical trials are not product based.

18. Submitting responses to information requests.

As per the eCTD guidance document, the electronic regulatory activity in eCTD format is the legal
document; therefore emails provided directly to the requestor have no legal value and are
considered a convenience copy. The information provided via email to the requestor must always be
followed by a regulatory transaction in eCTD format and provided no later than the time that is
stated on the information request.

19. Health Canada extensions to Information Requests.

If the company is not able to meet the requested timeline to provide the response, they should
contact the Health Canada requester.

20. Filing format for new molecules.

When filing for a new molecule, the filing in eCTD format remains optional as the CTA for the new
protocol is filed under the separate dossier ID, since the dossiers for clinical trials are protocol based
and not product based.

21. Filing format for subsequence Regulatory Activities and Transactions for a protocol.

Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent
regulatory activities for the same dossier must be filed in eCTD format. Sponsors must not revert to
non-eCTD electronic only format. However, with transfer of ownership, buy-outs or mergers, Health
Canada will assess the request on a case by case basis.

22. Processing time for transactions received via the CESG.

All Office of Submission and Intellectual Property processing times will remain as per the Guidance
Document: The Management of Drug Submissions and Applications. However, due to the short
review time for clinical trial regulatory activities, they are prioritized to be processed same day or
the next day, depending on the time of the receipt of the eCTD transaction.

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 Managing the lifecycle of the protocol in section 1.7.1 Study Protocol.

For information on the life cycle of some clinical trial related documents, refer to the Rules of
operation attribute for documents available on the Filing Submissions Electronically information
page.

23. Sequence/transaction descriptions for eCTD.

For information on transaction descriptions and placement document for CT-Notifications, refer to
the Table of Clinical Trials Regulatory Transaction (sequence) Descriptions and Placement document
for CT-Notifications sections posted on the Filing Submissions Electronically page.

24. Providing the Quality Overall Summary (QOS) and Investigational Medicinal Product Dossier (IMPD).

If quality documents are provided as part of the IMPD in lieu of the QOS, they should be filed as leaf
elements under the appropriate heading in Module 2 and 3. The QOS Document(s) should be
provided using one of the following two examples eCTD structures:

Example 1 – QOS and IMPD

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Example 2 – QOS and IMPD

25. Providing QOS and IMPD. (continued)

Additional acceptable structures below apply when the IMPD is provided in lieu of QOS. The QOS
Introduction is required when providing IMPD.

2.3 QOS
 Investigational Medicinal Product Dossier (IMPD) (PDF)
 QOS – Introduction (WORD)

2.3 QOS
 IMPD (PDF)
2.3.1 Introduction
 QOS – Introduction (WORD)

26. Providing and assigning Module 3.2.P attributes.

Each product should be provided under a separate “3.2.P” heading as follows:

3.2.P - Investigational
3.2.P - Comparator
3.2.P - Placebo

In the situation where the comparator is a cross-reference, the information should be placed in the
introduction section of the QOS. Therefore there is no need for a separate “P” section.

27. Providing Placebo information.

As per the ICH granularity document, Placebo information should be provided as multiple PDF files
as leaf elements under the appropriate heading in Module 3. However, if your tool allows a

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 document under the 3.2.P heading, then Health Canada would accept a single PDF document under
the 3.2.P heading (for clinical trial applications only).

28. Placement of the Certificate of Analyses.

The Certificate of Analyses should be provided for:

 pharmaceutical drugs under heading “3.2.P.5.4 Batch Analyses”;
 biologic and radiopharmaceutical drugs under heading “3.2.P.5.4 Batch Analyses” or “3.2.R.3
Lot Release Documentation”.

Other Lot Release documentation for BGTD should be provided in 3.2.R.3.

29. Provide meeting information.

If a meeting took place prior to the filing of a CTA or a CTA-A and the information has been provided
in non-eCTD format, the following should be provided:
 indicate on the cover letter the control number of the Pre-CTA meeting; and
 include the meeting minutes in the section 1.0.5 “Meeting Information”
If there was no meeting prior to filing the clinical trial regulatory activities/transaction, this can also
be mentioned on the cover letter.

30. Hyperlinks.

Refer to the eCTD guidance document section: 3.5 Hyperlinks and Cross-References for all
information on the hyperlinks.

31. The protocol life cycle approach for filing CTAs in eCTD format.

Health Canada has decided on the protocol life cycle approach based on the benefits below:
 eliminates the need to generate a new dossier ID with complete or partial transfer of
ownerships;
 eliminates the need to generate dossier IDs for each sponsor-product combinations;
 eliminates the need to generate a new dossier ID when a sponsor adds a drug to an existing
protocol, thus causing a new sponsor-product combination and inherently breaking the links
between amendments to a protocol;
 eliminates the need for Health Canada to allocate significant time to determine if a dossier ID
for a sponsor-product combo already exists when a new CTA/CTA-A is filed, at times requiring
extensive database searches; and
 overall, improves performance and minimises errors.

32. Protocol attachments and appendices as separate leafs in 1.7.1 Study Protocol.

Protocol attachments and appendices should not be provided as separate leafs in 1.7.1 Study
Protocol.

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33. CTA format for products already filed in eCTD format.

The CTA does not need to be filed in eCTD format after an NOC has been issued, only if that
particular CTA and protocol have been filed in eCTD format. Refer to section 5 of Important
Considerations When Preparing Regulatory Activities in Electronic Common Technical Document
Format of the eCTD Guidance document.

34. Reporting on serious unexpected adverse drug reactions for drugs used in clinical trials.

The reporting on the serious unexpected adverse drug reactions is out of scope for filling in eCTD
format as per Q#2. Each serious unexpected adverse drug reaction report that meets the reporting
requirements, including those from other studies/indications, should be submitted individually
following the procedure detailed below:

What and when to report:

Reporting requirements – Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications,
section 2.8.4.

Reporting requirements – Reminder for sponsors

ICH E2A Guidance Document – Clinical safety Data Management: Definitions and Standards for
Expedited Reporting

The ICH E6 – Good Clinical Practice, section 5.17, page 35

How to report:
Each ADR subject to expedited reporting should be reported individually using the CIOMS form.

The form can be sent via FAX to:

Therapeutic Products Directorate: (613) 941-2121, (613) 960-6587, or (613) 954-0941.

Biologics and Genetic Therapies Directorate: (613) 957-0364 (TPD fax numbers may be used if issues
are encountered with this number).

OR

The serious unexpected adverse drug reaction cases can be submitted using the electronic gateway
(E2B). For more information regarding the reporting via the E2B gateway contact Partner
Management Office (TPMO) at hc.tpmo-bgpc.sc@canada.ca.

35. Handling Information requests (signal assessments) received from the Adverse Drug Reaction (ADR)
division, Office of Clinical Trials, since these are usually product-related.

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 Responses to the requests from the ADR division have to be provided in non-eCTD format for the
time being. The instructions on how to provide the response will be included in the Health Canada
issued correspondence from the ADR division.

36. Submit Development Safety Update Reports (DSURs) that are product-related.

The DSURs can be provided either in eCTD or non-eCTD format as per the eCTD or non-eCTD
Guidance documents. If a DSUR is provided in eCTD format, a separate dossier IDs has to be
requested or it has to be provided under the existing product related eCTD dossier. Please refer to
the instructions on how to submit and when to submit.

37. Filing the Clinical Trial Site Information form.

The CTSI form can be found on Health Canada’s web site. Once the form is completed, it must be
sent via email as per the instructions provided with the CTSI form.

38. Filing information for medical devices for CTAs.

The information for medical devices can be filed under the 3.2.R.2 Medical Devices node extension.

39. Assigning a protocol number.

As per the Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving
Human Subjects) and Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications, the
Clinical Protocol Number must be assigned by the sponsor for each protocol when submitting the
CTA to Health Canada. Sponsors are encouraged to include a protocol number for Pre-CTA meeting
requests if available.

In general, a protocol number is a variable length, alpha-numeric sequence used by sponsors to

assign a reference number to their protocol. As per the Guidance for Completing the Drug
Submission Application Form, the protocol number for clinical trials should remain the same for the
duration of the trial.

When updating their documents, including protocols, sponsors should, in accordance with their
internal record/document management practices, apply version control principles. When submitting
a CTA-Amendment or Notification, sponsors should indicate the version or amendment number of
the protocol; however, certain best practices apply, as outlined below. These practices help to avoid
the incorrect issuance of dossier IDs, processing and tracking in Health Canada systems.

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The correct numbering of the protocol version or amendment provided in CTA-A or CTA-N is:

E.g.:

Best practices:
a. The complete root/original protocol number must always be indicated on forms and
documents where the protocol number is indicated eg: cover letter, protocol, HC/SC
3011, ICFs. It is not sufficient to only provide the version or amendment number
i. Correct: HCPM022 – Amendment 1
ii. Correct: HCPM022 – Version dated xxxxx
iii. Incorrect: 001
iv. Incorrect: Amendment 1
b. Adding prefix or suffix to indicate amendment numbers is not acceptable.
i. Correct: HCPM022 – Amendment 1
ii. Incorrect: 1-HCPM022-001
a. The amendment or version number should be indicated as outlined below:
i. Correct: HCPM022 – Amendment 1
ii. Incorrect: HCPM022 – 001

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Appendix A - Life Cycle Management at the Document Layer for eCTD Clinical Trial
Regulatory Activities

This page provides the rules for Use of Operation Attributes for Specific Documents (refer to
Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for information on how to
prepare a clinical trial application). This document should be used in conjunction with section 3.3.3 of
the Guidance Document: Preparations of Regulatory Activities in eCTD Format available on the Filing
Submission Electronically information page.

1. The Protocol  CTA: “New” when proving a copy of the final proposed protocol(s).
 CTA-A (Clinical):
 “Replace” when providing a revised protocol;
 “New” when providing an amended (or working) protocol (with a
clear description of the changes) for the first time;
 “Replace” when providing an amended (or working) protocol
(with a clear description of the changes) for subsequent
transaction;
 “New” when providing the list of changes, as a separate
document for the first time;
 “Replace” when providing the list of changes, as a separate
document for subsequent transaction.
 CTN – Protocol Update:
 “Replace” when providing a revised protocol;
 “New” when providing an amended (or working) protocol (with a
clear description of the changes) for the first time;
 “Replace” when providing an amended (or working) protocol
(with a clear description of the changes) for subsequent
transaction;
 “New” when providing the list of changes, as a separate
document for the first time;
 “Replace” when providing the list of changes, as a separate
document for subsequent transaction.

Note: Do not provide the last approved protocol submitted with the
CTA.
2. The Investigator’s  CTA: “New” when providing a copy of the current IB.
Brochures (IB):  CTA-A (Clinical): “Replace” when providing an updated IB.
 CTA-A (Quality) For Biologics and Radiopharmaceuticals only: “Replace”
when providing a revised IB.
 CTA-N: “Replace” when providing an updated IB.
 CTA, CTA-A, CTA-N: “Replace” when providing a correction of an error in
the IB.
 CTA-A and CTA-N:
 “New” when providing the tabulated summary of changes as a
separate document, for the first time.

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  “Replace” when providing the tabulated summary of changes as a
separate document, for subsequent amendments or notifications.

3. The Informed  CTA: “New” when providing a copy of the ICF.

Consent Forms  CTA-A (Clinical): “Replace” when providing a revised ICF.
(ICFs):  CTA-N: “Replace” when providing an updated ICF.
 CTA, CTA-A, CTA-N: “Replace” when providing a correction of an error in
the ICF.
 CTA-A and CTA-N:
 “New” when providing the annotated ICF for the first time.
 “Replace” when providing the annotated ICF for subsequent
amendments or notifications.

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Appendix B - Table of Regulatory Transaction (sequence) Descriptions

This section of the document is to provide additional information on placement of documents when
providing Clinical Trial Notifications.

For a list of all sequence descriptions for pre-CTA, CTA, CTA-A and CTN, refer to the Regulatory
Transaction Descriptions document available upon request at the webpage below.

For a list and placement of the module 1 documents refer to the Placement of documents in the
Regional Structure, available upon request.

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
products/applications-submissions/guidance-documents/filing-submissions-electronically.html

The regulatory activity type to be used for regulatory transactions in the table below is: CTA

Legend
{brief description} - required free text field no longer than 50 characters
{date} - required date in format of Year-Month-Day YYYY-MM-DD
{time} - required number, followed by one of the words hours/days/months
{version} - required document version number

Placement, Regulatory Transaction (RT) Descriptions for Regulatory Activity Type CTA
RT Description CTD Section(s) Comments
CTN-Administrative Change 1.2.9 Other Administrative 1. Section is for any administrative
to {brief description} Information1 information that does not fit in any
other subsection of module 1.
1.7.1 Study Protocol2
2. Administrative change to the
1.7.2 Informed Consent Forms3 protocol.

3. Administrative change to the ICF.

CTN-Appendix - {brief
description}
1
1.2.1 Application Forms 1. Template Authorisation for a Third
Party to Import the New Drug
1.2.3 Certification and Attestation Described in the Clinical Trial
Forms2 Application or Amendment -
Appendix 1 of HC-SC3011 form.

2. Template Authorisation for a Third

Party to Sign/File a Drug Submission
Application on Behalf of the
Manufacturer/Sponsor – Appendix
2 of the HC-SC3011 form (Clinical
Trial Notifications only).

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CTN-Contact Change - 1.2.1 Application Forms1
{brief description}
1.2.9 Other Administrative
Information2
3
1.7.1 Study Protocol
3. Summary of Additional Drugs
(SOAD) form – Appendix 4 of the
CTA guidance.
Add a descriptor as to which contact
has changed (e.g. submission contact,
sponsor, investigator).
1. For the Submission Application
form (HC-SC3011).

1.7.2 Informed Consent Forms4 2. All other contact related changes.

3. Contact change related to the

protocol.

4. Contact Change related to the ICF.

CTN-Data Safety 1.3.8.4 Other Pharmacovigilance Add a descriptor as to what the DSMC
Monitoring Committee Information has submitted (e.g. “Decision, Meeting
{brief description} dated Minutes, Recommendations”) followed
{date} by the date.

Example:
 CTN-Data Safety Monitoring
Committee Meeting Minutes dated
Oct. 12, 2011
CTN-Dear 1.3.8.3 Risk Communications If supporting documents are provided,
Investigator/Doctor Letter they must be placed in appropriate
sections in modules 1 to 5.
CTN-Diluent Change 3.2.P Drug Product Documents to be placed in the
appropriate module 3 subsection.
CTN-Drug Product Change 3.2.P Drug Product Documents to be placed in the
appropriate module 3 subsection.
CTN-Drug Substance 3.2.S Drug Substance Documents to be placed in the
Change appropriate module 3 subsection.
CTN-Enrollment 1.3.8.4 Other Pharmacovigilance If supporting documents are provided,
Suspension Information they must be placed in appropriate
sections in modules 1 to 5.
CTN-Ethics Board 1.7.3 Canadian Research Ethics Board 1. For Canadian REBs.
Communications dated (REB) Refusals1
{date} 2. For Foreign REB Refusals.
1.2.7 International Information2
3. REB attestation or Institutional
1.2.3 Certification and Attestation Review Board) IRB approval (if
Forms3 requested).

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CTN-IMPD Update
{version}
CTN-Informed Consent
Form Update {version}
CTN-Investigator’s
Brochure Update {version}
dated {date}
CTN-Informed Consent
Form {version} and
Investigator’s Brochure
{version} dated {date}
Updates
CTN-New Manufacturing
Site for {brief description}
2.3 Quality Overall Summary
1.7.2 Informed Consent Forms
1.3.4 Investigator’s Brochure
1.3.4 Investigator’s Brochure
1.7.2 Informed Consent Forms
3.2.S Drug Substance
3.2.P Drug Product
When providing IMPD in lieu of QOS,
include the version number if
applicable.
Example:
 CTN-Informed Consent Form
Updated Version 24
For version/edition include the number
only. For the date, use the date on the
IB cover page.
For supplements/addendums to IBs,
include the word Supplement or
Addendum after Update followed by
the supplement and addendum
number. Then add “to IB” followed by
the IB number.
Examples:
 CTN-Investigator's Brochure Update
11, dated Sep. 10, 2011
 CTN-Investigator's Brochure Update
Supplement 2 to IB 11, dated Sep.
10, 2011
For the IB version/edition include the
number only. For the date, use the date
on the IB cover page.
For supplements/addendums to IBs,
include the word Supplement or
Addendum after Update followed by
the supplement and addendum
number. Then add “to IB” followed by
the IB number.
Example:
 CTN- Informed Consent Form
(Version 24) and Investigator's
Brochure Version 11 (dated Sep. 10,
2011) Updates.
To be used only for CTA Notification
type changes in accordance with the
Guidance Document For Clinical Trial
Sponsors: Clinical Trial Applications.
Document to be placed in the
appropriate module 3 Drug Substance
or Drug Product subsections.
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CTN-New 3.2.S Drug Substance (when for DS) or Document to be placed in the
Packaging/Labelling Site appropriate module 3 Drug Substance
3.2.P Drug Product (when for DP) or Drug Product subsections.
CTN-New QC Testing Site 3.2.S Drug Substance (when for DS) or Document to be placed in the
appropriate module 3 Drug Substance
3.2.P Drug Product (when for DP) or Drug Product subsections.
CTN-New Summary of 1.2.3 Certification and Attestation If supporting documents are provided,
Additional Drugs Form Forms they must be placed in appropriate
sections in modules 1 to 5.
CTN-Packaging/Labelling 3.2.S Drug Substance (when for DS) or Document to be placed in the
Name Change appropriate module 3 Drug Substance
3.2.P Drug Product (when for DP) or Drug Product subsections.
CTN-Protocol {version} and 1.7.1 Study Protocol Example:
Informed Consent Form  CTN-Protocol Version 12 and
{version} Update 1.7.2 Informed Consent Forms Informed Consent Form Version 15
Update.
CTN-Protocol 1.7.1 Study Protocol If supporting documents are provided,
Update/Change {version} they must be placed in appropriate
sections in modules 1 to 5.
CTN-QOS Update 2.3 Quality Overall Summary If supporting documents are provided,
they must be placed in appropriate
sections in modules 1 to 5.
CTN-Refusals by Foreign 1.2.7 International Information If supporting documents are provided,
Regulatory they must be placed in appropriate
Authorities/REBs sections in modules 1 to 5.
CTN-Regulatory Hold 1.0.1 Cover Letter If supporting documents are provided,
they must be placed in appropriate
sections in modules 1 to 5.
CTN-Response to The sections of Modules 1 - 5 used will To be used only for responses to IRs
Information Request dated depend on what the IR is about. issued against a CTA Notification.
{date}*
*This sequence description should be
used when providing Responses to all
clarification requests issued for CTA-
Notifications.
CTN-Safety Update - {brief 1.0.1 Cover Letter Safety Update such as quarterly or ad
description} hoc reports.

If supporting documents are provided,

they must be placed in appropriate
sections in modules 1 to 5.
CTN-Shelf Life Extension 3.2.P Drug Product Documents to be placed in the
for DP-From {time}To appropriate module 3 Drug Product
{time} subsections.
CTN-Shelf Life Extension 3.2.S Drug Substance Documents to be placed in the
for DS-From {time}To appropriate module 3 Drug Substance
{time} subsections

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CTN-Site Closure 1.0.1 Cover Letter
CTN-Source Change of 3.2.S Drug Substance (when for DS) or
{brief description}
3.2.P Drug Product (when for DP)
CTN-Strain Change 3.2.S Drug Substance
CTN-Study Completion 1.0.1 Cover Letter
CTN-Study Discontinuation 1.0.1 Cover Letter1/2
due to {brief description}
1.3.8.4 Other Pharmacovigilance
Information3
CTN-Study Recruitment 1.0.1 Cover Letter
Timeline Extension
1.7.1 Study Protocol
CTN-Study Suspension 1.0.1 Cover Letter
CTN-Transfer of Ownership 1.0.1 Cover Letter
1.2.1 Application Forms1
1.2.6 Authorization for Sharing
Information 2
If supporting documents are provided,
they must be placed in appropriate
sections in modules 1 to 5.
Documents to be placed in the
appropriate module 3 Drug Substance
and/or Drug Product subsections.
Documents to be placed in the
appropriate module 3 Drug Substance
subsections.
If supporting documents are provided,
they must be placed in appropriate
sections in modules 1 to 5.
If applicable, the descriptor should
explain if the trial was discontinued
prior to initiation, due to business
reasons, lack of accrual, lack of efficacy
or due to safety reasons.
1. Non-Science.
2. If supporting documents are
provided, they must be placed in
appropriate sections in modules 1
to 5
3. If study discontinuation is due to
safety issue.
To be reflected in the Study Protocol
If supporting documents are provided,
they must be placed in appropriate
sections in modules 1 to 5.
Supporting documents should be placed
in appropriate sections in modules 1 to
5.
1. A completed HC-SC3011 form
should be provided.
2. Transfer of Ownership Letter(s), if
applicable.
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