NEW STUDY APPLICATION:

Primary Contact Regarding this Page / SMARTFORM VIEW / Changes to be made
(list all additions, deletions, where applicable, note if a mock up has been created) / ADDITIONAL SUGGESTIONS FOR REVISIONS
REBECCA / Study Identification Information / 1. Add study contact fields from former Clinical Trials Website Page
NO CHANGES / Medicare Coverage Analysis / NO CHANGES
Rebecca / Non-CSMC Sites /
  1. Revise to make applicable to all reliance situations, including new CTSA affiliated institutions (UCLA, Drew, LA Biomed). New revisions should also allow for reliance on other groups/institutions as allowed by CSMC IRB.

NO CHANGES / Financial Conflicts of Interest / NO CHANGES
Rebecca / Describing Your Financial Interest in the Research / 1. Revise view display so that all info entered is displayed in printed version
Rebecca / Developing A Plan To Address Significant Conflicts of Interest /
  1. Review compelling reasons section

Adam / NCI CIRB Approved Studies /
  1. Revise Item #1 to require separate uploads for each sub-item.
  2. Revise to be applicable for any situation where we rely on approval issued by non-CSMC IRB

Rebecca / Description of the Research / 1. See mock up- complete restructuring with plan to pull out Min Risk Research first
Sarvenaz / Analysis of Specimens and/or Data /
  1. See mock up- separate out questions and make them required.
  2. Added table to get rid of duplication of questions related to collection of data and/ or specimens

Rebecca / Center, Program Project and Training Grants
Rebecca / Lay Language Summary /
  1. See Mock Up. This to become a read-only page, pulling responses form other areas of application.

ADAM / Stem Cell Research / PAGE CAN BE REMOVED FROM FLOW; REQUIRED QUESTIONS INCORPORATED INTO DESCRIPTION OF RESEARCH/DEFINING SCRO REVIEW PAGES
ADAM / Defining Whether SCRO Oversight Is Required / 1. See mock-up
2. Added/moved questions to establish type of stem cell research being conducted
3. Added questions for research involving stem cell transplant
ADAM / Establishing Provenance of Existing Lines / 1. See mock-up
2. Added additional questions to determine if stem cell lines were acceptably derived
ADAM / Training for Embryonic Stem Cell Research / 1. Generalized to all iPSC research
2. Added questions relevant to derivation protocols
Study Background and Protocol /
  1. Make upload of scientific protocol a required element to address Sci Merit review needs, and study compliance needs.

REBECCA / Sample Size Information /
  1. See mock up
  2. Remove questions asking for description of reserach

NO CHANGES / CSMC Investigator Serves as Lead Investigator of a Multi-Site Study / NO CHANGES
Assessment of Potential Risk and Benefits
REBECCA / Inclusion and Exclusion Criteria /
  1. See Mock Up

REBECCA / Study Population Checklist /
  1. Page to be discontinued- relevant questions to be incorporated as part of inclusion and exclusion criteria

Sarvenaz / Children /
  1. See mock up: Queries to be incorporated into one table that allows user to list each different child group to be enrolled. This will allow for different responses for each child group.

No changes / Pregnant Women/Fetus / No changes
No changes / Fetal Tissue / No changes
REBECCA / Cognitively Impaired Subjects /
  1. Add new question #1, “Are you requesting approval to utilize a proxy consent process?” If yes, must address remainder of questions on page. If no, must address the following, “In response to Item X. on the page Process of Informed Consent, describe how you will assess that the subject posses the capacity to provide informed consent at the time they are approached.”

NO CHANGES / Employee and Student Subjects / NO CHANGES
NO CHANGES / Prisoner Subjects / NO CHANGES
Sarvenaz / Subject Identification and Recruitment /
  1. remove option 6 under question #2 pertaining to students or employees
  2. moved questions 2 and 3 from Recruitment and Payment for Participation to this page

Adam / Identifying Patient Subjects Via A Review of Medical Records /
  1. Add questions to address all HIPAA waiver elements explicitly

Sarvenaz / Recruitment and Payment for Participation /
  1. moved questions 2 and 3 to page “Subject ID and Recruitment”
  2. Specify type of recruitment document and whether it will be posted in or outside of CSMC- if outside marketing approval is required.

Clinical Trials Website
REBECCA / Clinical Research Summary Form / PAGE TO BE REMOVED FROM FLOW; REQUIRED QUESTIONS INCORPORATED INTO DESCRIPTION OF RESEARCH PAGE
NO CHANGES / Use of Placebo/Washout Periods / NO CHANGES
NO CHANGES / Radiation Safety Information / NO CHANGES
NO CHANGES / Procedures Involving Exposure to Radiation / NO CHANGES
MONICA / Use of Investigational Drugs or Biologics / See mock up. Consolidate questions from “IND Application for Off-Label Use of FDA Approved Drugs”. Page to now be used when an IND has been obtained for investigational drugs AND off-label use of FDA approved drugs.
MONICA / Use of FDA Approved Drugs or Other Products / See Mock Up. 1) Use of table format to list FDA approved drugs and approved uses, and prompt uploading of documentation normally requested in pre-review correspondence. 2) Hide/show function: Only necessary to describe PROPOSED use if it has been noted that there is a discrepancy between approved/proposed uses of a drug. If IND has NOT been obtained for off-label use, then this will activate IND Waiver questions. If IND has been obtained, then this will branch to the “Use of Investigational Drugs” page, resulting in the elimination of the “IND Application for Off-Label Use of Approved Drugs” page.
MONICA / Investigational New Drug Application Requirement for Off-Label Use / PAGE ELIMINTATED
MONICA / Use of Medical Devices / See mock up. Add required questions for FDA issued number and have a link to the FDA site. Expand regulatory statuses to include FDA approved under 510K. Prompt to upload documentation normally requested in pre-review correspondence. Hide/Show function: Activate questions for investigator-initiated studies if study identified as investigator initiated on “Study Identification” page.
MONICA / Investigational Use of Medical Devices- Risk Determination / Title change: “Investigational Use of Medical Devices-Risk Determination of Devices without an IDE.”
MONICA / Investigational Use of Significant Risk Medical Devices / NO CHANGES
NO CHANGES / Humanitarian Use Device / NO CHANGES
NO CHANGES / In Vitro Diagnostic Device / NO CHANGES
MONICA / Therapeutic Alternatives / NO CHANGES
Costs Related to Participation / NO CHANGES
NO CHANGES / Investigator Sponsor Responsibilities / NO CHANGES
Sarvenaz / Study Procedures Related to the Prospective Collection of Specimens /
  1. Revised to address previous issue of having no differentiation between specimens collected now table has been included with drop down options allowing study teams to describe each individual specimen collected and answer questions specific to that specimen collection.

Sarvenaz / How Will Specimens Be Collected /
  1. Removed page as questions are now answered as part of table on page “Prospective Collection of Specimens”

Sarvenaz / Repositories or other tissue /data storage /
  1. removed extra questions and added help template for repository management plan

Sarvenaz / Genetic Research /
  1. Minor addition to add help text reminder

Sarvenaz / Family Studies / Page Eliminated- necessary queries incorporated as part of Genetic research page
Rebecca / Surveys, Questionnaires and/or interviews /
  1. See Mock Up where propose to add questions in a table for each item noted.
  2. Include new query regarding validation of questionnaire in other languages

Rebecca / Informed Consent /
  1. Refine wording in some of options.

Rebecca / Process of Informed Consent /
  1. Queries already posed on the page, ‘Identification and Recruitment of Subjects” removed to minimize repetitive questions.

Rebecca / Documentation of Informed Consent / 1. Add show/hide functionality, to show Item #2 on this page, only if response regarding inclusion of Non-English speakers reflects intent to use short forms
NO CHANGES / Consent Process Where Signature is Not Required / NO CHANGES
Adam / Waiver of Informed Consent/Authorization /
  1. Add questions to address all HIPAA waiver elements explicitly

Adam / Consent Obtained Under Separately Approved Study / 1. Require separate uploads of both IRB Approval Document and IRB-Approved Consent form
NO CHANGES / Consent Requirements for Research with In Vitro Diagnostics / NO CHANGES
Gordon / Protecting Privacy Interests of Individuals /
  1. Combined overlapping questions for Privacy and Confidentiality screens, added new options for maintaining confidentiality.

Gordon / Maintaining Confidentiality of Data Collected /
  1. Combined overlapping questions for Privacy and Confidentiality screens,
  2. Added new options/questions to address use best practices for use of computers to store research data..

Gordon / Certificate of Confidentiality /
  1. Added new question to provide acceptable reasons for not obtaining a certificate of confidentiality

Monica / Data and Safety Monitoring Plan /
  1. See mock up. Revise questions to better identify the information that is being requested for the IRB.

Monica / Data and Safety Monitoring Plan (GCRC Studies) / NO CHANGES
Monica / Independent Monitor or DSMB / 1. RewordedItem #2 and #3 to make it clear what information the IRB is looking for in these responses.
NO CHANGES / Scientific Merit Review / NO CHANGES
NO CHANGES / Feasibility Considerations / NO CHANGES
Alissa / Case Report / NO CHANGES
Rebecca / Waiver of Authorization to Access PHI for Research / 1. RETITLE “Request to Access PHI for non-IRB regulated Activity”
Additional Information
NEW VIEW TO BE ADDED
(REBECCA) / CSMC Institutional Financial Conflict of Interest /
  1. Will include queries specific to situations where CSMC as an institution holds a financial conflict of interest and allow the research team to address why it is necessary to conduct the research at CSMC.

NEW VIEW TO BE ADDED
(REBECCA) / Forwarding data/specimens to a non-CSMC site /
  1. To be completed if DOR notes that CSMC is serving as a tissue/data collection site for a non-CSMC collection, including collections held by study sponsor

CONTINUING REVIEW APPLICATION:

Responsible Team Member / SMARTFORM VIEW / Changes to be made
(list all additions, deletions, where applicable, note if a mock up has been created) / ADDITIONAL SUGGESTIONS FOR REVISIONS
Adam / Type of Submission /
  1. Generalize for all facilitated review submissions
  2. Remove stem cell research option
  3. Hide/show item #4

Adam / NCI CIRB Approved Studies /
  1. Generalize for all facilitated review submissions
  2. Remove option to make changes to study materials

Rebecca / Subject Recruitment Information /
  1. Queries revised to include only totals for all subjects enrolled to date

Adam / Observations to Date /
  1. See mock-up
  2. Require additional information regarding DSMB reports
  3. Allow separate uploads for different reports
  4. Allow uploads for closure notices
  5. Add questions related to prior re-consent

Adam / Other Information Learned /
  1. Minor edits to text

Adam / OTHER PAGES – CHANGES TO HELP TEXT ONLY

AMENDMENT APPLICATION:

Responsible Team Member / SMARTFORM VIEW / Changes to be made
(list all additions, deletions, where applicable, note if a mock up has been created) / ADDITIONAL SUGGESTIONS FOR REVISIONS
MONICA / Amendment Information /
  1. Added new prompt to assess if similar amendment submitted for different study: "Has a separate amendment been submitted for THIS same change on a different study" (If yes, prompt to enter Ame# for related amendment)”
  1. Hide/show will be used to hide questions that are not applicable for studies that have not initiated subject accrual
  2. Added Help Text to remind study team to make corresponding edits to currently approved application.
  3. Question requiring description of changes removed. To be combined with question requesting justification for changes made on New Information page

MONICA / Change in PI of study /
  1. Revised wording of question to make it clear when it is necessary to upload an email from SRFA for a change in PI.

MONICA / New Information /
  1. Revised wording of Item #1 to require a summary of the proposed changes AND an explanation of why the changes are necessary.