January 2021: Thailand Regulatory Update

Updates to the Regulatory Portal (TCTR) post Maintenance Activity 

TCTR website has been upgraded and a new registration system is open for service from January 20, 2021, with the development of an application program in accordance with international standards.

With the new format, some items might have different requirements and there will be some additional mandatory items in accordance with WHO-ICTRP regulations. The styles and content of each topic including the use of the program may be modified as appropriate in the future without advance notice.

Based on the completion of the maintenance activity, a document has been made available to the registrants under the heading ‘Announcement for TCTR Registrants’. This document has the information on recent updates to the data fields required for registrants.Summary of changes in the parts that registrants use for registration are as follows (some changes present to original text due to translation):

  1.  Title

1.1 Change the Registration Site data selection to be a drop-down list instead of filling in the blanks and adjusting. Have the unique ID and URL information entered according to the Registration Site.

1.2 Can add more than one Secondary ID and add a summary as a table at the end of the header.Can be edited from the table

1.3 Change the Study Type from the original in the Title to the Design section.

  1. Ethics Review

2.1 Change the topic from the original name Oversight to Ethics Review.

2.2 Add part of the list of Date of Approval and Date of Exemption which will appear automatically according to Board Approval Topic Status

2.3 Able to add more than one Ethics review from the original list of only one. By choosing The Add more button will allow you to add additional information and add a table summary at the end of the header.

2.4 Cancel Data monitoring committee

  1. Sponsor 

In the Study Secondary Sponsor section, the method of posting the information is as follows: If you have this information

Please select As follows and fill in the appropriate blanks. In the event that you do not have this information, please select No Study.

Secondary Sponsor

  1. Protocol Synopsis

4.1 Changed the topic from the original Summary to Protocol Synopsis.

4.2 Add a list of URLs, Date and Version, if you have this information, please select URL as follows. And specify the data portions of URL, Date and Version respectively, and if you do not have this information, please select URL not available.

4.3 Cancel the Detailed Description list by putting the same information in the same box instead.

  1.  Health Conditions

Change the topic from the original name Conditions to Health Conditions, please enter the information according to the instructions in the table header.

  1. Status

6.1 Adjusted the key trial dates to be automatically assigned from the system to reflect the selected status.For example, if status is pending, not yet recruiting, the system will not allow key trial dates to be entered as dates in former

6.2 The system will automatically select whether the date in the key trial dates is anticipated or actual by comparison with the date you made the transaction

  1.  Design

There are differences between these two study types.

7.1 Study type should be selected as interventional or observational. So the individual topics will appear

7.2 Change the list of Primary Purpose, Study Phase, Intervention Model, Number of Arms / Groups, Masking, Allocation, Control, Study Endpoint Classification, Enrollment from original address. Below the section Secondary Outcome comes under the Design section clearly.

7.3 Adjust the information in various topics to be consistent, for example, if Intervention is selected. Model is Single arm. Number of Arms is automatically set to 1 or if Intervention is selected. Model is Parallel. Only 2 or more Number of Arms are allowed. In the part of Allocation. And the Control has been adjusted to match the selected Intervention Model as well.

7.4 In terms of Masking, the Single Blind and Double Blind items have been collapsed to become Masked. And for the Masked Roles section, there are 2 additional items which are Allocation Concealment. And Statistician

7.5 In the Control section, add No treatment / Standard of care options in the drop-down list.

7.6 Changed from the previous entry called Enrollment: Number of Subjects to Sample size: Planned sample size.

7.7 Add Actual sample size at study completion item which must be added in this section. In the event of Include Overall Recruitment Status in the Status section as Completed, Terminated, Withdrawn.

  1. Outcome

8.1 Adjusted Primary Outcome and Secondary Outcome to be placed side by side in the Outcome section and You can press Add more for more information. By adding a summary as a table at the end of the topic To be able to edit from the table

8.2 Cancellation of Safety Issues? Both in the parts of Primary Outcome and Secondary Outcome

  1.  Locations

In Section B, Section C and Section D in the Country section, you can select the country name from drop-down list instead of typing it as text.

  1. Summary Results

The system will open to provide detailed information in the box when Overall Recruitment Status is Completed,Terminated

  1. Added the section Deidentified Individual Participant-level Data Sharing.
  2. Title Publication from this study

12.1 is the collapse of the original topic, Citation and Links, to become Publication from this study.

12.2 Cancel recording the Citation and the Results Reference? That had existed in the original Citation topic

12.3 Cancel Description in the original Links section.

 

 

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