Principal Investigators
Phase I Clinical Trials
Clinical Areas
- 2 exam rooms
- 2 infusion chairs
- PK lab
- Pharmacy including hazardous drug storage and hazardous compounding areas
Clinical Equipment
- Crash cart and ACLS certified staff
- Infusion pumps
- Syringe pumps
- ECG machine
- Electronic vital signs monitoring and Accucheck
- All equipment is annually inspected and calibrated
- Patient Scale
ECGs
START uses a calibrated ECG machine with all procedures and time points performed in accordance with the protocol. Centralized readings are available when needed, in collaboration with central vendors.
Investigational Drug Section (IDS)
Drug Shipment
- START New Jersey
- ATTN: START – Genevieve Kumapley, PharmD, BCOP
- 629 Cranbury Rd., 2nd Floor, East Brunswick, NJ 08816
Pharmacy Equipment
- Refrigerator
- 1 pharmaceutical grade -20°C freezer
- 1 pharmaceutical grade -80°C freezer
- Secure medication storage with continuous temperature and humidity monitoring
- All equipment is annually inspected and calibrated
Medication Preparation
- Detailed storage, handling and preparation instructions are required.
- Procedure to prepare investigational drug
- Compatible IV bags and syringes
- Compatible IV tubing for infusion pumps
Medication Screening
Pharmacists screen and document prestudy concominant medications using protocol eligibility criteria, Lexicomp and Crediblemedgs.org to identify prohibited medications and other potential drug interactions of concern.
Drug Accountability
Master accountability log is maintained for each study. Due to the potential for staff exposure to hazardous materials, the IDS does not maintain any empty or partially empty container left from the preparation of investigational doses, this includes both IV and PO dosage forms.
Pharmacokinetics
PK Shipment Address
629 Cranbury Rd., 2nd Floor, East Brunswick, NJ 08816
Laboratory Equipment
- Refrigerated / room temperature centrifuges
- -20°C freezer with continuous temperature monitoring
- -80°C freezer with continuous temperature monitoring
Shipping Capabilities
PK department staff are IATA shipping certified. Specimens may be shipped same day, weekly, or monthly.
Biopsy Specimens
PK department staff sare present at the time of biopsy and process specimens according to protocol requirements.
Archival Specimens
- PK department staff request and process archival specimens
- Unstained slides are obtained and sent to sponsor or designee
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
START’s IRB of Record
Advarra IRB
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 Data Coordinator.
- 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
- Monitoring workspace with high-speed internet and computer for accessing the EMR
- WiFi available for EDC access
- Basic office supplies, copier, and telephone are available
- On-site monitoring hours are: Monday-Friday, 8:00 AM – 3:00 PM ET
Remote Monitoring Services
- START’s remote monitoring service allows the monitor to have access to our EMR and e-ISF (Veeva) systems without having to be onsite.
- Remote monitoring hours are: Monday-Friday*, 8:00 AM – 3:00 PM ET (*Flexible hours are available, provided that any adjustments are agreed upon between the coordinators and the monitors.)
Scheduling Monitoring Visits
- The START Data 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.
- Requests for co-monitors must be reviewed by the study team and approved by the Principal Investigator.
Hybrid Monitoring (Onsite and Remote)
- Monitors will be required to conduct onsite and remote visits during the following times:
- First monitoring visit and once per quarter may be conducted ONSITE.
- All other visits will be conducted REMOTELY.
