The standard and expedited versions of the Behavioral and Biomedical applications have been revised. While the content has received minimal updates, the order of the items has been changed. Questions that request related information have been grouped together to facilitate completion of the application. This is also a step toward a number of future DSICOVR-E and database enhancements. As always, we will accept the previous version of the applications through the next 60 days.
The KSP sections of the older IRB applications have been retired! DISCOVR-E will now serve as your official record for this information, which means that you no longer need to update your KSP tables in Sections 1-4, you can simply remove them when you submit amendments to update KSP. Please remember to change the version dates on your application as you remove these sections and give us a call if you have any questions.
We have recently created and uploaded new versions of the Children, Pregnant Women, and Prisoner vulnerable population forms. We hope these new versions will better capture pertinent study related information. You can check them out HERE.
The Health Sciences standard application and Dose Escalation Template Language have been revised to include additional information about therapeutic intent.
We have added a statement to clarify the need for completing the supplemental form for drugs/biologics if a Principal Investigator is claiming an IND exemption. This update affects Forms 1100 and 1135.
Some people have downloaded the Word (.doc) version of forms from our website only to have them become corrupted after editing and saving the document. We are currently searching for a pattern and resolution as to why this is happening. What we do know is that the corruption issues seem to be occurring most frequently for people using MS Office 2007 products (i.e., Word ’07). While the 2007 software is backward compatible with Office 2003, there appears to be an issue with the newer version trying to interpret the older version of the document. Until we have a definite solution, we’d recommend that MS Office 2007 users download the RTF (shown by the Apple logo on our website) version of the document(s) and use it for your study submissions. An RTF is a “rich text file” that can be used by both PC and Mac office software packages. Sorry for any inconvenience.
We’ve run into some technical difficulties with the MS 2007 documents. While we work a solution, Office 2007 users may want to download the RTF version of the form and convert it to a Word 2007 document. Sorry for any inconvenience. We hope to have this sorted out soon.
We’ve now added a MS Word 2007 version of all of our forms. Hopefully this will take care of any potential compatibility issues. If you encounter any bad links or error messages, please let us know. Thanks.
Form #1122 and accompanying instructions were updated to reflect the release of the Synthetic Derivative. In addition, new template language has been added to the “templates” page for use with studies using the Synthetic Derivative.
When we update our forms or create/delete a form, an annoucement will be posted here.
