Study Form: Many changes to many of the pages. Pages altered:
1 Project Identification: Minor changes - moved question about sponsor's protocol number to page 4
4 Type of Review: Show/hide for questions by campus of submission, addition of place for sponsor's template IC and passwords, sponsor's protocol number, now have hover over help for 4.1
4b. Exempt: Exempt: retooled page with more precise questions if check cat 2 or 4 in question 4b.
5. Study Locations: removed other sites options from 5.1. 5.2 and 5.3 altered to ask for other sites and coordinating site
6a. HSC Locations: 6.a.1. options - text alterations and a couple additions
6c. Other Sites: now only shows up if USC/CHLA is coordinating site (5.3), site listing indicates engagement
6c.1. Other Site: pop up page significantly altered to determine engagement, only show appropriate questions
7. No longer used (gone from formset)
8 and 8a Funding: consolidated into one page. New options available at 8.1 and the options selected determine subsequent questions on the page. For HSC, link to TRUE2 studies now works and link can be created and removed from this page.
9. Methods and Procedures: Significantly retooled to first ask if study will involve prospective and/or retrospective data, subsequent questions depend on answers. The study procedures question (9.2) now only shows up if prospective is selected and instead of three questions it is now consolidated into one question. Some selections at 9.2 bring up red reminders (pathology specimens, controlled substances, creation of a repository, and radiation exposure other than clinically indicated. 9.3, sponsor/investigator question was reworded.
10, 11, and 12: Red HSC instructions hidden for other campuses, retooled on 12 to include CHLA.
13 Retrospective studies: renumbered (used to be 14) and new question on deceased individuals added, with instructions and link if study is only using decendents.
14. Biohazardous substances: renumbered (used to be 13)
15. Creation of a Repository: now has instructions and less fields.
15b. Submission of data to existing repository: new page for CHLA, uses a form based on their worksheet.
17. Drugs and Biologics: edited to include reference to biologics and for clarity.
21. Surveys/Questionaires: Removed 21.1. because description was duplicating set of measures attached at 21.2
22 Special Subject Populations: Neonates are broken out from pregnant women and have own page. Edited some options for clarity
22c. Adults not Competent: Significantly added to in order to increase compliance with state law. yes/no questions and checkbox answers for the most part
22d. Non-English Speaking Subjects: moved here from page 41. A few editorial changes as well as reminder that the IRB may require a certificate of translation if the investigator supplies the translation.
22e. Minors: renumbered from 22d. Minor categories now link to the regulations.
22f. Pregnant Women: Significantly retooled to increase compliance
22g. Neonates: new page for newborns
22i. Prisoners: new additions for Epidemiological research options.
23.
24. Subject Recruitment and Informed Consent: this page now replaces elements of 24,29,30,31 and 34 in the old form. Combined together with checkbox options and only showing the questions that need to be filled out
24A. Assent: new page. Similar to 24, but focused on the assent process instead of consent.
24P. Parental Permission: new page. Similar to 24, but focused on Parental Permission.
25. Financial Obligation and Compensation: retooled with radio buttons for the available options. Selecting some of the options will prompt the user to input the text needed in the consent, pre-populated with the relevant consent template language from the institution. The contract administrator from HSC has the option of altering and locking the responses to 25.1 and 25.3 in order to maintain consistency with the contract.
26. Privacy and Confidentiality: questions now have checkbox options with the availability of an "other" text box.
27. Risks: questions now have checkbox options with the availability of an "other" text box.
28. Risk Benefit Analysis: questions now have checkbox options with the availability of an "other" text box.
29-34: No longer used (gone from formset) Data is at 24, 24A, 24P, and 22c (for adults not competent to consent).
35. HIPAA Applicability: questions edited
37. Decedents: New page for HIPAA presentations necessary when using decendents personal health information.
38. Waiver of HIPAA: questions now have checkbox options with the availability of an "other" text box.
39. Conflict of Interest (USC): Now includes a question on the management plan (checkbox options), and COI reviewer can adjust and lock answers.
41. Moved to 22d.
Edit Study Personnel: New activity available to PIs and Study Contact Persons to alter the non-essential study personnel for an approved study without an open amendment. All study personnel excepting the PI, Co-Is and Faculty Advisor can now be altered and added to without the need to create an amendment. Only people with valid human subjects training are allowed to be added. For full board studies, the person to be added must have valid GCP. Other changes to study staff still require an amendment.
Return for Pre Review: new activity available to the IRB to return a study for review by department, division, faculty advisor, or the cancer center (HSC). The study will return to the place it was sent from (in the workflow) following the needed approvals.
Hover Help: New feature for having small amounts of help text show up at the end of a question when a small question mark icon is clicked or hovered over. Currently only being used on question 4.1
Hide/Show: many more occasions that this is being used to hide questions that are not required to be answered.
Exempt, coded, and retrospective formsets are not wholly contained in the main formset for consistency and maintainability.
Available activities on a projects's workspace are now grouped according to type of activity.
Many activity icons have been changed to better indicate what the activity will do.
Continuing Review: Reportable Event page now has the option to see Auto-Acknowledged Adverse Events. The user can switch between the set of all adverse events and the set without the Auto-Acknowledged events at will.
CHLA will also now be using the Incidental Findings pages (28a on main study, 8a on Continuing Review) for studies using MRIs.
The email notification to the USC CRO for reportable events is now more precise.
The USC Cancer Center no longer has to review purely retrospective studies.
IRB Director Workspace now includes the ability to search for studies by person in 2.1.
The IRB Director workspace now warns for pending NHSR applications and also only shows the correct set from the campus.
Studies that have qualified for the USC Flexibility Policy will now get yearly reminder emails regarding funding.
the approved study tab on the continuing review has been updated
waivers that the study qualifies for now is shown to the IRB staff and reviewers so that they can be documented easily.
FDA waiver guidance on page 24 has been updated
Including a number of bug fixes, quality and speed improvements, and display issues resolved.
