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

B2B Research B2B Research Online Portal FAQsOnline Portal FAQs

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

(March 2010)(March 2010)

Frequently Asked Frequently Asked QuestionsQuestions

1. 1. Our application was submitted just before Our application was submitted just before the submission deadline. However, it was the submission deadline. However, it was not accepted for the month’s DSRB full not accepted for the month’s DSRB full board review. Why was this so?board review. Why was this so?The submission deadline for a particular month’s full board review The submission deadline for a particular month’s full board review is the is the first working day of that same monthfirst working day of that same month. When the online . When the online application form is submitted, it will be forwarded to the Department application form is submitted, it will be forwarded to the Department and Institution representatives (DR & IR) for review and and Institution representatives (DR & IR) for review and endorsement. endorsement.

The The DSRB can only accept the online application form after it DSRB can only accept the online application form after it has been endorsed by the DR and IRhas been endorsed by the DR and IR. Henceforth, study team . Henceforth, study team members are strongly encouraged to prepare and submit their members are strongly encouraged to prepare and submit their applications ahead of the deadline, and allow time for the DR and applications ahead of the deadline, and allow time for the DR and IR to endorse the applications.IR to endorse the applications.


2. The Investigators are unable to update 2. The Investigators are unable to update their minimum training status in the their minimum training status in the account profile. Why is this so?account profile. Why is this so?

The The minimum training status can only be updated by the DSRB minimum training status can only be updated by the DSRB staffstaff. If the Investigator has completed the training requirements . If the Investigator has completed the training requirements but the status has not yet been updated, please contact your but the status has not yet been updated, please contact your Domain Coordinator. You can also fax a copy of the CITI certificate Domain Coordinator. You can also fax a copy of the CITI certificate to 6496-6257 (Attn: Nor-DSRB). If the Investigator completed other to 6496-6257 (Attn: Nor-DSRB). If the Investigator completed other relevant training courses such as GCP workshop, he/she can fax a relevant training courses such as GCP workshop, he/she can fax a copy of the certificate, together with the Waiver of CITI Certification copy of the certificate, together with the Waiver of CITI Certification Form to DSRB.Form to DSRB.


3. I have a report on local death in non-NHG 3. I have a report on local death in non-NHG site that is unrelated and unexpected. I site that is unrelated and unexpected. I cannot submit it through UPIRTSo online. cannot submit it through UPIRTSo online. Why is this so?Why is this so?Before submitting the report, please ensure the following criteria Before submitting the report, please ensure the following criteria are met:are met:

Occurrence within Local (NHG) Occurrence within Local (NHG) sitessites

• Can be related/unrelated

• Can be expected/unexpected

Occurrence in non-NHG Local Occurrence in non-NHG Local (Singapore) or Overseas Sites(Singapore) or Overseas Sites

• Must be related

• Must be unexpected

IMPT: Local (NHG) refers to study sites under the oversight of the NHG DSRB. These include all NHG Institutions, NUHS, AH and Lilly-NUS.


Examples of “Local (NHG)” sites

Examples of “Local (Singapore)” sites

Select Study Site


Ensure that this is checked as “YES” if the death occurred in “Local (NHG)” sites.


Choose from the list of countries


Please check the appropriate boxes.

IMPT: “Local deaths” here refers to incidents occurring within study sites under the oversight of NHG DSRB.

For Feedback, For Feedback, Suggestions or Suggestions or Questions on B2B Questions on B2B Online : Online :

Email: [email protected]

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


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


Helpline: 6496 6979 (Office hrs)


Helpline: 6496 6979 (Office hrs)

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

http://www.b2bresearch.nhg.com.sg/

http://www.b2bresearch.nhg.com.sg/

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

Documents

oversight of nhg dsrb

nonnhg local singapore

study sites

nhg institutions

study site slide

local deaths

months dsrb

nonnhg site