CRC Protocol Implementation and Activation Guidelines

Once your protocol is approved by the SAC, contact the CRC Nurse Manager (witkowskicindyl@uams.edu) (501-526-7984) to start the implementation process. 

An implementation conference will be scheduled at the CRC.  This meeting will cover protocol specific instructions by the PI and his/her staff to insure accurate data collection.  With your permission we would ask to tape the implementation meeting and make it available to CRC personnel that are unable to attend.  Representatives from the following departments will be present to discuss specific study requirements:  Nursing, Laboratory, Bionutrition, and Informatics. 

Each department will require specific items to assist you with your study.   Please have the following information available for the CRC staff at your implementation meeting.

Nursing 

• IRB approval letter documenting approval of the study and a letter documenting the date of current approved consent if different from the study approval.

• Copies of case report forms or source documents used for data collection. 

• Copy of physician's orders that will be used.

• Study specific requirements, including specialized equipment, supplies, or medications.

• Frequency of vital, signs, blood draws, meds, urine collections, etc.

• Emergency contact names and numbers.

• IRB review:  The study must have IRB approval prior to implementing on the CRC.

• VA R&D review:  If subjects will be scheduled for a visit at the CRC home site located at the LRVA the study must have VA Research and Development approval prior to the scheduled visit on the CRC.  The Study Physician is also required to obtain VA credentialing prior to implementing on the CRC.  The CRC has the VA R&D packets available for your use and can assist you with this process.

Laboratory

Lab will need a contact name and phone number for lab processes on protocol specimens, the number of blood draws or urine samples collected at each visit, the tube type to be used, ml of blood in each tube, how many tubes are anticipated, tests requested, spinning time and temperature for samples, labeling desired, and storage instructions with breakdown of expected processing by each visit in the protocol.  Please also note any special instructions, tests, or lab related supplies that you are requesting.  The CRC Laboratory requires the form below to be completed and returned to Subraman Ranganathan, PhD, prior to activation of a study.

Bionutrition

For protocols involving minimal metabolic kitchen or other bionutrition support, the implementation meeting usually provides sufficient information exchange and detail clarification. However, protocols involving intensive bionutrition support such as a controlled feeding study or studies involving a special diet, a test diet, or an extended inpatient stay require contact with the bionutritionist prior to the general implementation meeting with the entire CRC staff. The bionutritionist may be reached by phone at 501-526-7670 or via email at wellsamandam@uams.edu.

Informatics

Studies requiring significant informatics support (datasets to be stored, databases to be created, considerable end user support for equipment or software) should contact the informatics core (501-526-7665 or harrisrichardm@uams.edu ) prior to the implementation meeting if at all possible.  If your protocol will be using the CRC server, Informatics will require a written or emailed list of people with authorization to edit or view your project data on the CRC server.  You are encouraged to contact informatics prior to implementation if you will be collecting or storing data in electronic format.  Waiting until the implementation meeting to discuss informatics needs could result in delays of application development in time for the start date of your study.

Remember, Informatics and Biostatistics are available for study design consultation and suggestions in data collection prior to and during SAC submission and when finalizing data collection forms prior to initiation of the study.

It is the responsibility of the Principal Investigator to provide the CRC Staff with the necessary information on the study protocol, subject characteristics, physician coverage, and IRB approval prior to enrollment of the first subject.

Please note that all publications that result from utilization of any of the CRC resources should cite grant number M01RR14288 as a contributing source of support and that the CRC will need a copy of the publication.

If you have any questions, please call Cindy Henrich (HenrichCindyL@uams.edu) at 526-7664.