STANDARD OPERATING PROCEDURES - Emory University

Emory University IRB

STANDARD OPERATING PROCEDURES

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Table of Contents ............................................................................................................................................................. 2

ADMINISTRATIVE .......................................................................................................................... 6

SOP Portfolio Modifications .............................................................................................................................................. 6 Listserv Responsibilities .................................................................................................................................................. 10 Mass Email Listerv Management .................................................................................................................................... 14 IRB Staff Study Checklists/Worksheets/Other documents Updates ............................................................................... 19 Onboarding New IRB Staff .............................................................................................................................................. 20 IRB Department Travel.................................................................................................................................................... 22 Evaluating IRB Staff Performance ................................................................................................................................... 25 Inquiries & Complaints received about IRB submissions ................................................................................................ 29 Staff Continuing Education ............................................................................................................................................. 32 IRB Staff Meeting Facilitation.......................................................................................................................................... 33

COLLABORATIVE RESEARCH / CENTRAL IRBS .............................................................................. 34

External Collaborators Included in Initial Submissions or in Modifications to Approved Non-Exempt Research ........... 34 Obtaining Access to WIRB and NCI CIRB ......................................................................................................................... 37 WCG Listserv Duties ........................................................................................................................................................ 38 NCI CIRB studies processing ............................................................................................................................................ 46 Reportable New Information (RNI) Submission Notification Process for External IRB Studies....................................... 53 Vetting NIH Single IRB Plans............................................................................................................................................ 57 XIRB Study Processing When Emory Relying on An External IRB Other than the NCI CIRB............................................. 59 XIRB Study Processing for Studies Transitioning from Emory IRB Approval to External IRB Review .............................. 65 Closing Out Multi-Site Studies ........................................................................................................................................ 66 Issuing Partial HIPAA Waivers for XIRB Studies............................................................................................................... 68 Processing New Studies When Emory is the Single IRB of Record (sIRB) for a Multi-Site Study ..................................... 69 Processing Modifications When Emory is the Single IRB of Record (sIRB) for a Multi-Site Study................................... 73 Processing CRs When Emory is the Single IRB of Record (sIRB) for a Multi-Site Study ................................................... 74

MEETING FACILITATION .............................................................................................................. 75

Meeting Facilitation Responsibilities .............................................................................................................................. 76 Drivers for IRB meetings ................................................................................................................................................. 86 Minutes Processing Procedures ...................................................................................................................................... 87 In Office Meeting Preparation ........................................................................................................................................ 93 IRB Member Onboarding ................................................................................................................................................ 95

QA AND EDUCATION ................................................................................................................... 99

Acknowledgments & Noncompliance Determinations Made by Senior Team Q Staff ................................................... 99

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IRB Noncompliance ....................................................................................................................................................... 101 IRB Team Q CAPA Follow Up ......................................................................................................................................... 105 CMTE Q Meeting Facilitation ........................................................................................................................................ 107 Communication of Report of Internal Study Subject Death.......................................................................................... 110 Review of Single Use, Expanded Access of Unapproved Drugs or Devices ................................................................... 112 External Webinars presented by Team Q ..................................................................................................................... 117 Process of Review of Consent Process Errors after Notification from OCR.................................................................. 119 Informed Consent Monitoring SOP ............................................................................................................................... 122 Internal QA/QI review of documents after IRB Review................................................................................................. 124 Letters after FB with PIs, OHRP and FDA after SNC, CNC and UP determinations ........................................................ 126 Reportable new information submission Review Process ............................................................................................ 127 Education and Quality Assurance Team Mission and Process ...................................................................................... 135 IRB Record Review of Studies approved by the Emory IRB........................................................................................... 137 Review of Safety Reports submitted by sponsors holding an IDE ................................................................................. 140 Routing External UPs (FDA Regulated).......................................................................................................................... 142

S-I SUBMISSION MANAGEMENT ............................................................................................... 145

New study screen process for S-I studies...................................................................................................................... 146 CR screen process for S-I studies .................................................................................................................................. 148 Modification (MOD) submission screen process for S-I studies.................................................................................... 150 Closeout submission screen process for S-I studies ...................................................................................................... 153 S-I, Single IRB Study Screening Process ......................................................................................................................... 155

STUDY MANAGEMENT .............................................................................................................. 157

Not Research/ Not-Human-Subjects/Not-Human-Subjects-Research/Not-Engaged.................................................... 157

MODIFICATIONS........................................................................................................................ 162

Adding/Removing Study Personnel............................................................................................................................... 162 Modifications- Processing from Preliminary Analysis through Approval ...................................................................... 175 Modifications: Mods Indicating Increased Risk............................................................................................................. 181

NEW STUDIES ............................................................................................................................ 183

Pre-Review options and Ancillary Review Information ................................................................................................. 183 eIRB Processing of New Study Applications- Preliminary Analysis through Approval................................................... 187 Naming Conventions for eIRB Studies........................................................................................................................... 194 RDRC Studies................................................................................................................................................................. 195 Translation of Informed Consent Documents ............................................................................................................... 197 Research Projects led by Non-Emory students ............................................................................................................. 200 Training Verification...................................................................................................................................................... 201

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Electronic documentation of informed consent via "electronic signature" or "digital signature") .............................. 205 Mobile Devices and Mobile Medical Apps Used in Research........................................................................................ 212 Certificate of Confidentiality Process in non-federal studies ........................................................................................ 219 Data sharing certifications including genomic data sharing.......................................................................................... 225 COI: Handling Studies with Study Team Conflict of Interest ......................................................................................... 227 Institutional Conflict of Interest .................................................................................................................................... 233 Cost Option for Clinical Trial Agreements and ICFs....................................................................................................... 236 Sensitive Study Status ................................................................................................................................................... 238 Imaging Studies ............................................................................................................................................................. 240 How to Handle GWAS Data Use Certification Requests................................................................................................ 242 Humanitarian Device Exemption (HDE) Studies............................................................................................................ 243 as a recruitment tool .................................................................................................................... 247 Checking Biosafety Approval Status.............................................................................................................................. 248 Processing Studies that will use Deception or Incomplete Disclosure .......................................................................... 249 Looking Up `In Case of Injury' Option for Industry-funded Studies via ORA Reporting Export ..................................... 252 St. Joseph and John's Creek study site process............................................................................................................. 258 REMS study review ....................................................................................................................................................... 260 Prisoner Studies: Handling of New/Modification/Renewal Submissions when Prisoners are Subjects (Application of Subpart C) ..................................................................................................................................................................... 263 VA Studies with non-VA Sites ? IRB Submission Requirements .................................................................................... 268 Determinations and Reviews by IRB Staff ..................................................................................................................... 270 Categories of Research Reviewable by IRB Staff as IRB Designated Members ............................................................. 272 Assigning New Studies to IRB Analysts.......................................................................................................................... 275

DURING STUDY CONDUCT ........................................................................................................ 279

Over-Enrollment Via Consent (No Research Activities including during Screening) ..................................................... 279 Transferring Study Participants Between Study Sites ................................................................................................... 281 Fixing Errors in eIRB System.......................................................................................................................................... 283 Continuing Review Processing-Preliminary Analysis through Approval........................................................................ 287 Continuing Review: Applying 30-day window............................................................................................................... 293 Continuing Review: REs/PDs/Noncompliance and Monitor Reports ............................................................................ 295 Continuing Review: Processing study staff noncompliance with CITI and Clinical Research Training (formerly Key Concepts/Intro to CR) requirements............................................................................................................................. 298

CLOSE OUT ................................................................................................................................ 300

Close-Out Process ......................................................................................................................................................... 300 Informing Teams of Study Closure ................................................................................................................................ 305

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