Program Infrastructure

The Mental Health and Addictive Disorder Research Program cores:

1. Administration: Our administrative team oversees and manages grants administration and budget and contract development.

2. Clinical Core: Our clinical core is comprised of research clinicians (physicians, nurses, social workers, and psychologists), study coordinators, medical technicians and a program director. Together they oversee and coordinate all clinical activities.

3. Regulatory: Our regulatory team oversees and coordinates communications with Institutional Review Boards, hospital committees, study sponsors and the Food and Drug Administration.

4. Training: Our training group oversees staff education around Good Clinical Practice and Human Subjects Protection as well as protocol-specific training.

5. Data Management: The Information Sciences Division (ISD) at the Nathan Kline Institute (NKI) supports many of our data management, study design and analysis activities.

6. Quality Assurance: QA activities are supported both internally and by a group from the ISD at NKI. QA monitors regulatory, clinical and data compliance locally in addition to outside monitoring.

Our clinical research space and resources include patient interviewing and testing rooms, two exam/treatment rooms, access to several research pharmacies, on-site facilities for biological sample collection, preparation and shipping, a cue-reactivity and EEG laboratory and an acoustic startle laboratory, storage space for archived data, and a reception area with clerical, photocopying and fax capabilities. All staff offices have high speed internet access. Our core clinical setting is located at the Manhattan Campus of the VA NY Harbor Healthcare System which is a full spectrum tertiary level medical, surgical and psychiatric facility with emergency and critical care services. MHADRP studies are also carried out in the NYU General Clinical Research Center (GCRC) and in collaborating community-based treatment programs in the New York Metropolitan area.

Biomedical equipment at our site includes EKG, EEG, refrigerators, temperature-monitored freezers and ultra-freezers, refrigerated and bench-top centrifuges, otoscope / ophthalmoscope / sphygmomanometer, a calibrated scale, acoustic startle testing equipment, networked computers with internet access.

We use a prescreening protocol to improve efficiency for potential volunteers and for the clinic. During initial phone contact a brief summary of studies is provided and appointments are made for a prescreen visit. Information collected allows us to direct volunteers to appropriate studies and streamlines recruiting by reducing screen-fail rates and increasing enrollment.