Clinical Trials Center UNM HSC

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Rules and Regulations

GUIDE TO THE CLINICAL TRIALS CENTER

Hours: 0730-1600 M-F

Phone: (505)272-2836



I. SCHEDULING AND ROOM RESERVATIONS

Please reserve rooms at least 72 hours in advance. We can not guarantee that rooms will be available for last-minute exams (walk-ins). The more notice we receive, the better we will be able to accommodate specific exam rooms at convenient times. The CTC operates on a first come, first serve basis. Only one room will be allowed per protocol with a maximum of two rooms per coordinator, space permitting.

Appointments should be scheduled with the CTC staff at least 72 hours prior to the patient's appointment time. Medical records require 72 hours advance notice to retrieve patient charts. Walk-ins will be seen, if time permits, but medical records will not be retrieved. Please be courteous and double check your schedule with the CTC schedule. If you have a cancellation, please inform the CTC staff as soon as possible. If you do not cancel the room reservation at least 24 hours prior to the visit, you will be charged for a 20-minute "no show" visit. Please contact your patients at least 24 hours prior to visit to confirm the appointment.

The correct procedure for scheduling is:

Talk to the CTC secretary/staff regarding available time slots on schedule.

Write down available time slots.

Talk to patient regarding his/her availability based on available time slots.

Confirm time slot with CTC staff--Give staff patient name, protocol number, visit number and approximate time needed to complete the visit.

Scheduling must be between the study coordinator and CTC staff. No appointments will be made by CTC staff directly with patients, unless CTC is coordinating the study. It is the patient's responsibility to call the coordinator for cancellations and the coordinator's responsibility to notify CTC of cancellations. Please give your office and pager number to your patients. Do not give them CTC's number--we will not take messages for you.

To confirm that your appointments are scheduled with the CTC, it is advised that you meet with the secretary weekly to compare appointment times. This also enables adequate room space and procedure time for each patient. We cannot guarantee room space and nursing personnel if adequate notice is not given.

It is the responsibility of each coordinator to clean up the exam room after each visit. If the CTC has to clean the room, the investigator will be charged for an extra 20-minute "room cleaning" visit.



II. LABORATORY CONSIDERATIONS

If you are not using the UH lab, you will need to make arrangements for pick-ups. A comparison list of lab fees are available at the CTC. If you are using an outside laboratory, you need to have your specimens packaged and ready for pick-up by 1500. SmithKline Beecham picks up daily, Monday-Friday, at 1530. All SmithKline Beecham specimens are to be taken to the GCRC lab, on 5-East, and placed in the SKB pick up box. FedEx specimens need to be ready for pick-up by 1500 and taken to the 5-East nurses' station for pick-up. Airborne pick-ups must be called into Airborne by the research coordinator. Airborne will coordinate with the research coordinator the pick-up time and place. (We are informing you of existing pick-ups for labs and not suggesting you use any of the above laboratories. This will be your choice.) Your accounts, pick-ups, and deliveries of results, must be set up with the laboratory of your choice before your study begins.

DRY ICE--Dry ice can be ordered through Chemical and Research Laboratory Supplier (CRLS) at 272-5109. Each coordinator is responsible for setting up an account with CRLS in order to purchase dry ice.

III. STORAGE AND EQUIPMENT

Do not stock any items in the exam rooms. Laboratory and pharmacy supplies, for active protocols only, may be kept in the lab and pharmacy, respectively. When a study closes, please remove all your supplies promptly as space is limited and can be used for new studies. If supplies are not removed in a timely manner, they will be put in the trash.

IV. WORKROOM

The workroom, which is located between Procedure Room 2 and the manager's office, is available to all active research personnel and their monitors. There are three desks (one per study, please), phones, a computer, and a Xerox machine. The workroom is not considered a reserved area. This area must be shared by all studies at all times. Please be courteous, polite and respectful of your fellow research persons. No personal items, case report forms, etc. can be left in the CTC. No exceptions will be made without prior written approval from the manager.

The Xerox machine is the property of the CTC. If you need to make copies, you need to go to your designated department and use your code for Xeroxing. If copies are made in the CTC, there will be a charge of $.10/page to the investigator which will be added to your monthly bill.



V. CTC APPROVAL FORMS: Once the CTC has received the protocol, consents, HRRC approval letter and signed calculations sheet the protocol will then be sent to the CTC Medical Director for approval. Once approved, you may start making appointments for your patients.

VI. MEDICAL RECORDS

All medical records including consent forms are the property of the CTC and are not to be removed from the CTC unless signed out. Medical records will be provided by the CTC, on request, for the first and last visits only unless other arrangements have be made with the CTC Department Secretary. If you want to review charts or need charts for monitor reviews, it is your responsibility to retrieve and return them.

VII. PHARMACY INITIATION FEE

All drugs will be shipped through the UH Pharmacy. There will be an initiation fee from pharmacy. Jim Simpson is the Research Pharmacist. He can be reached at 272-2515.

VIII. QUALITY ASSURANCE

The Clinical Trials Center is currently conducting quality assurance surveys in the following areas:

Informed Consents.

Wait Time for appointments.



IX. FORMS

Each study has its own requirements as to what forms and reports are needed to complete the study. The CTC has additional forms that each coordinator is responsible for completing on each patient that is seen in the CTC. These forms are: Significant Diagnosis Sheet, Discharge Instruction Sheet and Patient Assessment and Teaching Record. A CTC Study Enrollment Form is available directly from the internet.

X. MISCELLANEOUS

The guidelines apply to any and all people conducting business in the Clinical Trials Center. A professional demeanor is expected at all times regardless of who your employer is.

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