Page 215 - CHST Research Administration eBook 2 of 2 (Q4 2021)

SECTION 2
Study Coordination: Study Maintenance & Study Close-Out
OVERVIEW OF SECTION CONTENT
Study Maintenance
Regulatory & IRB
R100 Ordering Study Supplies
R101 Regulatory Binder
R101a Clinical Essential Resource Resource (CRER)
R102 Creating Study Logs
R103 Reportable Events
R104 Modifications
R105 Continuing Review
R106 Internal Audits
R107 Effort Justification & Attestation
(EJ&A)
Budget & Contract
R108 PreparingandTrackingyourResearch
Billing Report (RBR)
R109 EPIC Billing Compliance
R110 ClinCard
Study Visit Procedures
R111 Consent Process
R112 Consenting Using Language Line/
Interpreter
R113 Fax R113a R114 R115 R116 R117 R118 R119 R120
Consent by Email, Regular Mail or
eConsent Telephone Visit
Lab Bags & Kits
Lab Requisition Sample and Processing Lab Ordering Medication Orders
Research Infusions
Study Close-Out
R200 Study Closure
*ATTENTION: During time of Pandemic, our institution and department utilize a command structure to modify operations in accordance with the laws, CDC guidance, and within strict safety and regulatory compliance. Therefore, please follow the RA guidance in the Introduction of this book to observe the necessary precautions are taken in fulfillment of this standard operating procedure. All activates permitted under the current structure, should be 1) in line with the current guidance, 2) approved on a case by case basis as applicable (see Introduction RA guidance), and 3) adapted to virtual methods of completion whenever possible.