B2B Research Online Portal FAQs Chicken Soup for the Busy Coordinator (February 2010)

Frequently Asked Questions 1.Can I still submit paper forms to DSRB? With effect from 1 Jan 2010, DSRB is phasing out paper submission. All new applications must be submitted online. You are also strongly encouraged to submit the supplementary forms online. For older protocols that were submitted to DSRB in the hardcopy format, paper submission of supplementary forms will still be accepted. 2.Where can I attach the Investigator Self-Assessment Checklist? You can attach the completed Investigator Self-Assessment Checklist at the end of the “Study Status Report Form”.

Frequently Asked Questions 3.How can I submit or amend the application form on behalf of the PI? The PI must first initiate a new application form with his/her own account and enter the Study Title. The PI should then nominate a Protocol Administrator (PA). Once this is done, the application form can be saved as a draft and the PA can complete the application form thereon. However, please note that the system only allows the PI to submit the completed application form. 4.What are the access rights of the Protocol Administrator? The PA is responsible for administrative matters relating to the study. The PA can be study coordinator, research nurse or clinical research associate, and need not be part of the study team. The PA has the same access rights to the online study folder and can assist the PI in completing the various online forms and reports. However, please note that the system only allows the PI to submit the forms and reports.

Frequently Asked Questions 5.Study Amendment: I deleted the obsolete study document in the system, and can no longer upload the tracked changes version. What should I do? Do not click on the “delete” button. Please refer to the next 2 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.

For Feedback, Suggestions or Questions on B2B Online : Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore Helpline: (Office hrs) Helpline: (Office hrs) For Feedback or Suggestions for CRCS :