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Troubleshooting HSCT Forms
Forms uploaded as "User-attached Forms" on the S2S tab in Kuali Coeus are provided by Grants.gov. The current form is posted to the SPA Forms page as soon as we are aware of, and have tested, the updated form.
This is a list of some issues identified by UMB that have caused validation or uploading errors on the Human Subjects and Clinical Trials Information Form (HSCT form).
Use Adobe Reader to open and work on the form.
Only one person should open and work on the form before it is uploaded into Kuali Coeus. Grants.gov states: "If more than one person is entering text into an application package, the same version of Adobe Reader software should be used by each person. Check the version number of the Adobe software on each user's computer to make sure the versions match."
Attachments must be PDF files
All attachments must have short, unique names. "Protection.pdf" or "HumanSubj.pdf" is sufficient. In all cases, but especially if you are attaching multiple Human Subject Study Records, watch for file names that are similar. We had an error caused by similar file names.
Use only letters and numbers in file names. Do not use apostrophes, periods, ampersands, or other characters. Hyphens and underlines are probably OK.
Certain special characters will cause an error on uploading the form. The error appears at the bottom of the S2S tab and reads: "The Xml File (Xml File) may only consist of visible characters, spaces, or tabs."
When possible, key information directly into the form. Copying/pasting from Word or other sources can result in the xml error.
DO NOT USE: degree sign, underline (including > or < symbol), Greek letters
The following have been OK in submitted proposals: > < + ^ ~ % $
Apostrophes and Quotes: Unless you are keying information directly into the form, find all instances of apostrophes and quotes and overwrite them from within the form.
Errors related to NIH instructions:
1. if using an existing dataset or resource, cumulative counts for racial and ethnic categories must be greater than zero. (034.6.13)
2. A response of N/A to the Multi Site Study Protocol question on study is valid only when the application is for a Career Dev or Fellowship Funding Opportunity Announcement, OR the study is exempt from Federal Regulations (Question 1.2a = yes). (034.7.3)
3. a brief summary of the protocol cannot be provided since you did not answer "Yes" to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. (034.8.30)
4. The submitted NCT# for study is not a valid ClinicalTrials.gov identifier. A ClinicalTrials.gov identifier references a clinical trial that has been registered with ClinicalTrials.gov and must be in the format "NCT" followed by eight digits (e.g. NCT12345678). (034.5.7)
5. Although attachment Project 1 Planned enrollment report.pdf is in PDF format, it uses a technology for fillable form fields (XML Forms Architecture - XFA) not currently supported by eRA systems. Recreate the attachment using a different PDF generation tool. Contact the eRA Service Desk if additional assistance is needed. (000.11)
6. Protection of Human Subjects attachment is required for Study Record (034.7.1)
7. A response to the question regarding multi-site studies is required for Study Record (034.7.2)
8. If you answered "Yes" to the "Are Human Subjects Involved" question on the Other Project Information form, you must provide at least one Study Record or Delayed Onset Study. (034.3.1)
9. If you answered "Yes" to the question "Are Human Subjects Involved" on the Other Project Information form, a "Yes" response to the question "Does the proposed research involve human specimens and/or data" is not a valid response. (034.2.3)
10. A response to the question regarding multi-site studies is required. (034.7.2)
11. For study titled ... an Intervention cannot be provided since you did not answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. (034.8.57)
12. Study Record and Delayed Onset study titles must be unique and cannot be duplicated in an application (000.41) (NIH instruction: "Enter a brief, unique title that describes the study the participants will be involved in. Each study within your application must have a unique Study Title. The first 150 characters will display in the application image bookmarks.")
When an Adobe form has been edited and re-edited multiple times, you may see other errors upon uploading. Check to make sure all the attachments to the Human Subject Study Record are listed on the S2S tab. If not, your form may be corrupted. If you get a Kuali Coeus Incident Report screen, your form is almost surely corrupted. You may be able to upload the completed Human Subject Study Record to a new HSCT form to resolve the issue. If not, then you will need to start over.