B2B Research B2B Research Online Portal FAQsOnline Portal FAQs

Chicken Soup for the Chicken Soup for the Busy Coordinator Busy Coordinator

(February 2010)(February 2010)

Frequently Asked Frequently Asked QuestionsQuestions

1.1. Can I still submit paper forms to DSRB?Can I still submit paper forms to DSRB?

With effect from 1 Jan 2010, DSRB is phasing out paper With effect from 1 Jan 2010, DSRB is phasing out paper submission. All new applications submission. All new applications mustmust be submitted online. be submitted online. You are also strongly encouraged to submit the You are also strongly encouraged to submit the supplementary forms online. For older protocols that were supplementary forms online. For older protocols that were submitted to DSRB in the hardcopy format, paper submission submitted to DSRB in the hardcopy format, paper submission of supplementary forms will still be accepted.of supplementary forms will still be accepted.

2.2. Where can I attach the Investigator Self-Where can I attach the Investigator Self-Assessment Checklist?Assessment Checklist?

You can attach the completed Investigator Self-Assessment You can attach the completed Investigator Self-Assessment Checklist at the end of the “Study Status Report Form”. Checklist at the end of the “Study Status Report Form”.

Frequently Asked Frequently Asked QuestionsQuestions

3.3. How can I submit or amend the application form How can I submit or amend the application form on behalf of the PI?on behalf of the PI?

The The PI must first initiate a new application formPI must first initiate a new application form with his/her with his/her own account and enter the Study Title. The PI should then own account and enter the Study Title. The PI should then nominate a Protocol Administrator (PA)nominate a Protocol Administrator (PA). Once this is done, the . Once this is done, the application form can be saved as a draft and the PA can application form can be saved as a draft and the PA can complete the application form thereon. However, please note complete the application form thereon. However, please note that the system only allows the PI to submit the completed that the system only allows the PI to submit the completed application form.application form.

4.4. What are the access rights of the Protocol What are the access rights of the Protocol Administrator?Administrator?

The PA is responsible for administrative matters relating to the The PA is responsible for administrative matters relating to the study. The PA can be study coordinator, research nurse or study. The PA can be study coordinator, research nurse or clinical research associate, and need not be part of the study clinical research associate, and need not be part of the study team. The PA has the same access rights to the online study team. The PA has the same access rights to the online study folder and can assist the PI in completing the various online folder and can assist the PI in completing the various online forms and reports. However, please note that the system only forms and reports. However, please note that the system only allows theallows the PI to submit the forms and reports.PI to submit the forms and reports.

Frequently Asked Frequently Asked QuestionsQuestions

5.5. Study Amendment: I deleted the obsolete study Study Amendment: I deleted the obsolete study document in the system, and can no longer document in the system, and can no longer upload the tracked changes version. What should upload the tracked changes version. What should I do?I do?

Do not click on the “delete” button. Please refer to the next 2 Do not click on the “delete” button. Please refer to the next 2 slides on how to supersede the old study documents. slides on how to supersede the old study documents.

Please share the information with other Study Coordinators and Principal Investigators.

DO NOT click on the “delete” button!

Step 1: Check the box for document you want to supersede.

Step 2: Select the amendment category

Step 3: Click “Attach”

Step 5: Check “Track Change Copy”

Step 4: Fill in the title, document version and document date.

Step 6: Provide a short description of the document.

Step 7: Browse for the file and click “Attach”. The document will appear on “File Name (Changes Highlighted)” column of the main document table (see previous slide).

Step 8: You will return to the main document table (previous slide). Repeat the steps to attach the clean/final copy.

When the amendment is approved, the study document will appear in the study document library.

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Email: crcs@nhg.com.sg

Clinical Research Coordinator Society c/o Research & Development Office6 Commonwealth Lane#04-01/02 GMTI BuildingSingapore 149547

Email: crcs@nhg.com.sg

Clinical Research Coordinator Society c/o Research & Development Office6 Commonwealth Lane#04-01/02 GMTI BuildingSingapore 149547

Email: B2BAdmin@nhg.com.sg

Helpline: 6496 6979 (Office hrs)

Email: B2BAdmin@nhg.com.sg

Helpline: 6496 6979 (Office hrs)

For Feedback or For Feedback or Suggestions for Suggestions for CRCS : CRCS :