Pre-study Start up with the Clinical Trials Office (CTO)
Purpose
The purpose of these guidelines is to provide answers to frequently asked questions at the time of pre-study start up. These guidelines have been established to meet the needs of both the Clinical Trials Office and the sponsor.
Facilities:
University of Utah Hospital
50 N. Medical Drive
Salt Lake City, Utah 84132
Primary Children's Hospital
100 N. Mario Capecchi Drive
Salt Lake City, Utah 84113
Eccles Outpatient Clinic
80 N. Mario Capecchi Drive
Salt Lake City, Utah 84113
Clinical Trials Office (CTO) Staff
We provide dedicated study support for industry sponsors from study start-up to close-out providing Clinical Trial support ensuring ongoing quality of service and compliance of all research with Federal regulations and ICH guidelines for Good Clinical Practice (GCP). We provide high quality, world class research in an academic setting.
Our teams consist of:
- Business Development and Marketing
- Budget and Finance Team
- Compliance and Quality Assurance Team
- Contracting and Legal
- Regulatory Team
- Research Coordinator Pool
Confidentiality Agreements (CDAs)
| CDA FAQs | |
| Is a Confidentiality Disclosure Agreement (CDA) required to be in place at the University of Utah (Primary Children's Hospital) before study documents are received? | We require a Confidentiality Disclosure Agreement (CDA) be completed by the University of Utah (PCH) prior to providing information and receiving the protocol and other study start-up documents. |
| Can a Principal Investigator (PI) sign a CDA on behalf of the University of Utah?
|
No. PIs do not have the authority to sign and execute CDAs. CDAs for a clinical trial must be reviewed, negotiated, approved and signed by the UU signatory in the Office of Sponsored Projects (OSP) at the University of Utah. |
| Who should receive the initial CDA for processing?
|
Initial CDAs should be sent to Jaci Skidmore (jaci.skidmore@hsc.utah.edu) who will facilitate the execution with the OSP team within the CTO. |
| Is a separate CDA required for University of Utah and Primary Children's Hospital? | The UU and PCH fall under the same "covered entity" so one CDA will cover both the UU and PCH. All physicians in both facilities are faculty at the UU. |
| Who receives the fully executed CDA and what is the next step? | OSP forwards the fully executed CDA to Jaci Skidmore who then receives the feasibility, protocol and study documents for review. |
IRB and Other Review Committees
| IRB/Regulatory FAQs | |
| What type of review agency does your site use? | We use a local IRB and have limited capacity for C-IRB |
| Can you use a central IRB/EC? | Yes, if there is a reliance agreement in place with C-IRB. |
|
What is your local IRB address/contact information?
|
Institutional Review Board
|
| What is the IRB RWA Assurance Number? | FWA00003745-U Utah |
|
What is the review timeline for the IRB?
|
Once submitted to the IRB, they have an 18-day pre-review.
During this pre-review they will request administrative revisions to the ICF, application, etc. The full IRB review date is assigned approximately 3 weeks after submission to the IRB. |
| What is the average time for IRB approval at your institution? | 8-12 weeks assuming there is adequate communication between the site and sponsor and/or CRO. |
| Does your site have a scientific review board that will need to approve the study in addition to the IRB/EC? | No, PCH has an ancillary review and then forwards approval to the UU IRB to begin Pre-review. |
|
What other committees must review the study?
|
The Radiation Drug Research Committee (RDRC): review occurs once the study has been submitted to the IRB if the study has scans, x-rays, or radiation therapy. Once the RDRC has approved the trial (2-4 weeks) the study will be automatically submitted to the IRB.
Institutional BioSafety Committee: If the trial involves an agent that is formulated from recombinant DNA or genetically modified material, the Institutional BioSafety Committee will also have to review and approve the study prior to IRB final approval. This can be reviewed simultaneous to the IRB final approval. This can be reviewed simultaneous to the IRB and adds approximately 3 weeks to review time. |
| Does your site utilize E-signatures on IRB/IEC approval documents? | Yes |
| Does the IRB/IEC allow expedited approval for minor changes? | Yes |
| Has your site ever undergone an audit or regulatory inspection? If yes, was your site cited? | Yes. No 483 issued. |
Contracts (OSP)/Budgets
| Contract/Budget FAQs | |
| What is the average time for your site to execute a clinical trial agreement (contract) with the sponsor after receipt of the final protocol? | Under 2 months assuming there is adequate communication between site and sponsor and/or CRO. |
| Can the budget/contract be done in parallel with IRB/IEC submission? | Yes |
| Does your site require contract execution prior to IRB submission? | No |
| Is your site obliged to use its own unique contract template? | No |
| What is the current F&A Rate? | 36.5% |
| What is your Tax ID Number? | The Tax ID number will be provided during budget and contract negotiations. |
| Will your site accept a unilateral CDA or CTA? | No. We require a mutual CDA and CTA to protect both parties confidentiality. |
Investigational Drug Services (IDS)/Pharmacy
| Investigational Pharmacy/Drug Dispensing FAQs | |
|
Investigational Pharmacy contact for UU
|
Investigational Drug Services (Provides IDS to both HCI and UU) Huntsman Cancer Hospital
Susan Sorenson, PharmD., CCRP |
| Do you use a pharmacist for preparing drug infusion? | Yes |
| Do you use a pharmacy for storage and dispensing of drug supplies? | Yes |
| Are your drug storage refrigerator temperatures monitored on a daily basis? | Yes |
Electronic Data Capture (EDC) and Medical Records
| EDC and Medical Records FAQs | |
| Does the site have EDC experience? | Yes- numerous EDC systems are used for trials conducted at UU and PCH. |
| Does the site have IVRS/IWRS experiecne? | Yes |
| Are Electronic Medical Records (EMR) used for trials? | Yes- We use EPIC as our EMR system with shadow charts for monitoring at UU and Help 2 at PCH. |
| Is the EMR CRF part 11 compliant? | Yes. Letter of attestation available upon request. |
| Are study records archived after IRB closure? | Yes- records are archived for a study specified time period usually determined during CTA. SOP available upon request. |
General Information
| FAQs | |
| How is GCP Training Completed? | GCP Training is completed through CITI GCP modules by Investigators and Staff. Certificates available upon request. |
| Monitoring Visits | The CTO has adequate space for monitoring. Each monitor is reserved a space with access to Wi-Fi, copier, phone and fax. |
| Site Initiation Visit (SIV) | The SIV will be scheduled by the Lead CRC. |
| Archiving | Study records will be stored by the CTO in archives for up to fifteen years. SOP upon request. |
| Does your site have experienced phlebotomists for pediatric blood draws? | Yes, our study staff have extensive experience with pediatric blood draws. |
Is additional investigator background available on request?
Yes, more information may be obtained once an investigator has been identified including:
- The patient population to which the investigator has access
- The investigator's research study experience
- The number of research studies the investigator has conducted and in which specific disease(s) or condition(s)
Is the Principal Investigator an appropriate site staff familiar with applicable regulatory requirements for conducting a clinical trial?
Yes. We require ongoing training not only with our PIs, but we require ongoing training with all study staff.
Does your site have adequate coverage for all involved personnel (Principal Investigator, Study, Coordinator, Pharmacists, etc.) in the event of holidays or illness?
Yes. We will always provide coverage for any trial in the event of illness, holidays and vacations.
List of most commonly requested equipment available for clinical studies at our site: (more upon request)
- 12 Lead Electrocardiogram (EKG/ECG) machine
- Crash cart
- Calibrated min/max thermometers
- Ambient Centrifuge
- Refrigerated Centrifuge
- Pediatric Blood Pressure Cuff and Calibrated Manometer
- Calibrated Weight Measurement Device (Scale)
- Height Measurement Device (Stadiometer)
- Dedicated, Lockable -20 degrees Celsius Freezer
- Dedicated, Lockable -70 degrees Celsius Freezer
- Dedicated, Lockable -80 degrees Celsius Freezer
- Dedicated, Lockable Research Refrigerator
- Fully Equipped Emergency Crash Cart
- Infusion Pumps
- Endoscopy/Colonoscopy Equipment
- Dexascan
Leadership
J. Michael Dean, MD, MBA
Associate Dean for Clinical Research
Professor
Vice Chairman for Research
Department of Pediatrics
Director, Clinical Trials Office
Chief, Division of Pediatric Critical Care
University of Utah School of Medicine
Contact Us
Phone: 801-587-7514
Email: ClinicalTrialsOffice@hsc.utah.edu