Known Issues 2/2/18

February 2, 2018

Known issues on the new PHS Human Subjects and Clinical Trials Information (HSCT) Form

Please note that a number of issues have been identified when using the new PHS Human Subjects and Clinical Trials Information (HSCT) Form and additional steps may be required to ensure successful submission.

A list of the known issues is included below with additional information on how to work around each specific issue. Please review the list carefully. If you have any questions or if ITS can assist in any way, please contact the ITS Service Center.

Study Record Enrollment table not calculating correctly - ITS Action Required.

In the Cumulative (Actual) table, the racial category rows are not totaling correctly (row totals).

Suggested Workaround: Enter the data in the table cells. Once you are done with the entire Human Subjects and Clinical Trials Information form, submit a ticket to ITS and we will run a script to fix the totals for you. Note that this needs to be done after all other errors are cleared. ITS will need to re-run the fix every time the form is saved.

If you have already submitted your proposal: Check NIH Commons to see if a correction is required. If a correction is required, contact the PR listed on the PAF (ORSP or Medical School Grants Office) prior to the proposal deadline.

Issue resolution date: 2/23/2018

Study Title on the Study Record errors if title is greater than 30 characters.

This was the subject of the January 23, 2018 RAPid.

Suggested Workaround: Limit the field to 30 characters, even though NIH allows 600 characters.

Issue resolution date: 2/6/2018

N/A option for No Minimum or Maximum Age is not working.

On the Study Record, in Section 2. Population Characteristics, Item 3. Age Limits, the drop-down option to indicate no age limits isn’t working correctly.

Suggested Workaround: Insert 0 for a minimum age limit and 100 for a maximum age limit.

Issue resolution date: 2/6/2018

Display order for the study records and delayed onset studies not respected.

If you have multiple study records and/or delayed onset studies, the form allows you to set a display order. However, this display order is not being consistently respected in the generated PDF or in the data sent to NIH. The data will be submitted to the NIH, however, it may not be in the order you indicated.

Issue resolution date: 2/6/2018

A few text boxes are truncated on the Generated PDF.

In the Study Record, Section 4. Protocol Synopsis, the Brief Summary and Study Design (Narrative Study Description) are truncated in the Generated PDF. This is only a display issue on the PDF in eRPM. The data we send to the sponsor includes all of the entered text.

Issue resolution date: 2/23/2018

Document uploaded not appearing in the Generated PDF.

The document uploaded in the Delayed Onset Studies section isn’t appearing in the Generated PDF. It is, however, included in the data we send to the sponsor.

Issue resolution date: 2/23/2018

Additional note regarding special characters

The new HSCT form includes more text fields and you may be cutting and pasting text from other documents to complete these fields. This process could introduce more characters, such as hyphens, quotation marks, etc., into your proposal. The system reads these as special characters. If you want to include these characters, you will need to check the box for special characters on the Validate Activity.