Principal Investigators
Phase I Clinical Trials
The START Carolinas clinic has a dedicated treatment room that includes exam rooms, treatment chairs, infusion pumps, and local laboratory services.
Clinical Areas
- 1 triage/blood draw station
- 1 procedure room
- 2 treatment and exam rooms with infusion chair and bed
Clinical Equipment
- Crash cart and ACLS certified staff
- Infusion pumps
- Syringe pumps
- EKG machine
- Electronic vital signs monitoring and Accucheck
- All equipment is annually inspected and calibrated
ECGs
- Our clinicians have experience with utilizing ELI 150 and ELI 250 equipment from central vendors.
Investigational Drug Section (IDS)
Pharmacy Equipment
- 1 biological safety cabinet
- Secure medication storage with continuous temperature monitoring for both cold storage and room temperature storage
- 1 pharmaceutical grade -20 C freezer
- 1 pharmaceutical grade -80 C freezer
- Refrigerator
- Room temperature storage shelving (20-25 C)
- All equipment is annually inspected and calibrate
Medication Preparation
- Storage, handling and preparation instructions are followed.
- Compatible IV bags, syringes, and tubings available
- Braun Infusomat pumps for syringe pump dosing available
- Approved closed system transfer device
Medication Screening
- Clinical research coordinators screen and document pre-study concomitant medications using protocol eligibility criteria, identify prohibited medications and other potential drug interactions of concern.
- Investigator confirms and signs off on eligibility.
Drug Accountability
- Master accountability log is maintained for each study.
- Due to the potential for staff exposure to hazardous materials, the IDS will not maintain any empty or partially empty container left from the preparation of investigational doses, this includes both IV and PO dosage forms.
Pharmacokinetics
Biopsy Specimens
Staff processing PK samples are present at the time of biopsy at ASC and ship tissue according to protocol requirements or send to pathology lab for processing based on protocol requirements.
Laboratory Equipment
All equipment is annually inspected and calibrated and includes the following:
- 1 refrigerated room temp and 2 room temperature centrifuges
- 1 pharmaceutical grade -20C freezer
- 1 pharmaceutical grade -80C freezer
- Refrigerator
- Room temperature storage shelving
Shipping Capabilities
Staff processing PK samples are IATA shipping certified. Specimens may be shipped same day, weekly, or monthly.
Archival Specimens
- Staff request and process archival specimens
- Unstained slides are obtained and sent to sponsor or designee
- Tumor blocks and slides are obtained based on pathology lab policy
Specialty Labs
PK department staff routinely process and ship to Central lab specimens such as biomarkers, PBMCs, DNA, hair follicle specimens, and other specialty labs.
Regulatory Affairs & Data Management
Requirements for IRB Submission
- Final protocol
- Investigator Brochure (IB)
- IND number
- Patient stipend
- Consent form template, which should contain:
- Reading at a grade level 8.9 or below
- Total blood volume (in mL) required per protocol
- Injury statement language
- Drug Diary Template
Standard START Templates & Training
- Site Initiation Visit (SIV) Log
- Site Signature / Delegation of Authority Log
- Staff complete Good Clinical Practice (GCP) Training & Protection of Human Research Subjects (PHRS) every 3 years via the NIDA Program
Data Entry Capabilities
- Every study has a dedicated START Clinical Research Assistant (CRA). START has experience with a wide variety of electronic data capture systems (i.e. Medidata RAVE, InForm, Tempo, DataTrak, etc.). START ensures clean, accurate, and timely data entry and query resolution.
- 10 business days for data entry
- 5 business days for query resolution
On-Site Monitoring Area
- 2 monitoring rooms with WiFi available for EDC access
- Copier, scanner and fax machines are available
- On-site monitoring hours are: Monday-Thursday from 9am – 4pm EST and Friday from 9am-1pm EST
Remote Monitoring Services
- Remote monitoring is available
- Remote monitoring hours are Monday-Friday from 8am-5pm EST or extended hours by request
Scheduling Monitoring Visits
- The START Regulatory Coordinator is the main point of contact for the scheduling of all on-site and/or remote monitoring visits (i.e. initial, interim, and close-out visits, etc.).
- Monitor visits must be scheduled at least 30 days in advance (recommend 6 weeks).
- Requests for co-monitors must be reviewed by the study team and approved.
Hybrid Monitoring (Onsite and Remote)
- Onsite monitoring is preferred but remote monitoring is available based on need.
