Related questions in:

Nursing:
1. How can I get my study started in the CRC?

You must first call the Director of Patient Care Services, Sue Cascio, to schedule a meeting for a protocol initiation meeting.

2. How do I schedule an appointment for subjects in the CRC?

You must call the Director of Patient Care Services, Sue Cascio, to schedule an appointment for your subject.

Laboratory:
1. What services does the CRC Laboratory offer?

The UIC CRC Laboratory offers the following services: sample processing and specimen shipping (see #2& #3). The UIC CRC Laboratory also has a radioisotope laboratory facility for investigators wishing to do radioisotope studies. It houses a -80°C and a -20°C freezer for temporary storage of biological samples drawn as part of CRC investigators’ studies.

2. Shipping biological specimens is subject to an extensive set of rules. Will the CRC do the shipping? What does the investigator need to provide?

The CRC staff can ship samples for you. We observe the following guidelines:
· The investigator must provide all packing material (e.g. styrofoam and cardboard boxes). You may order them from Fisher Scientific (general number: 1-800-766-7000, UIC on-campus extension 3-0324).

· The investigator must also provide the CRC Laboratory with a courier service account. This includes courier airbills (filled with the recipient address and the account number to be billed). Courier services that can handle biological specimens include Federal Express (1-800-GOFEDEX) and Airborne Express (1-800-247-2676). Please contact them directly to set up an account. If the specimens to be shipped are known to present an increased risk to the carrier (i.e. blood containing HIV), we suggest you call the above numbers and talk to the hazardous material manager to assess your particular needs.

· The CRC Laboratory provides wet and/or dry ice for shipping of samples that are temperature-sensitive.

· The CRC lab will pack the specimens in the provided material, arrange for pick up by the courier service, and -upon request- track the package delivery.

Pharmacy:


1. What types of services can pharmacy provide for my study?

The Investigational Drug Service offers a range of research activities to help ensure the delivery of high quality healthcare, while minimizing the risks associated with participation in a research study. It is the goal of the service to assist and support the investigators in meeting their obligations in conducting research studies in the Clinical Research Center. Examples of services include ensuring drug storage is appropriate, dispensing of appropriate protocol-specified doses, randomization of research subjects, study medication counseling, and maintaining accurate drug accountability logs.

2. Will the pharmacy provide the medications needed for my study?

Pharmacy can obtain and provide the medications needed for studies, however, the investigator is responsible for all costs of these medications, as well as any preparation costs (i.e. labels, IV bags, and syringes).

3. Can I dispense medications to the patient or is this the responsibility of the pharmacist?

For research subjects located in the CRC, it is a requirement that the pharmacy handles and dispenses all drugs, herbal supplements, and controlled substances. Arrangements can be made for the pharmacy to dispense medications on an outpatient basis.

Bionutrition:

1. What services does the Bionutrition Core provide to investigators?

The Bionutrition Core is directed by a full time research–trained dietitian. The Bionutrition Center, in addition to developing research meals, has a metabolic cart for testing of energy expenditure, anthropometric equipment for measuring body composition and nutritional software (Nutrition Data System for Research) for analyzing diet composition available for research studies.

2. Can the Bionutrition Center prepare special diets?

The Bionutrition Center has a food preparatory laboratory equipped with the food supplies and equipment necessary for developing and preparing controlled diets for research studies.

Bioinformatics:

1. I have a new protocol. Whom should I talk to for help in setting up a database?

Questions regarding setting up, importing, exporting, or backing up databases should be directed to the CRC Informatics Manager, Weimin Liang; phone: (312) 413-3254; email: weiminl@uic.edu.

For data analysis question please contact the CRC Biostatistician, Dr. Craig Beam; phone: (312) 996-1589.

2. What database software should I use?

The CRC currently uses Microsoft Access and Microsoft SQL 2000 (SQL 2000). Microsoft Access is sufficient for small scale database.

3. What if I don’t have access to or don’t know how to use MS Access or SQL 2000?

You can create your data in Microsoft Excel or any available spread sheet program. Once you have your data in tables, you can contact the CRC Informatics Manager, Weimin Liang, for help in exporting data to the database of your choice. When nessesary, the CRC Informatics Manager will be available for trainning on these database.

4. What type of database might I need if my research is part of a multicenter study?

Your database may have limited usefulness if users can only access it at a designated computer. However, by using the internet, you may design your database so it can be accessed from any computer. All insert, update and delete to any record in the database will need a valid login ID and password through a secure internet connection. Please contact the informatics manager to setup a web database.


5. How secure is it, when accessing the data on the Internet?

SQL 2000 provides a highly secure means to access data. The CRC Informatics Manager will take every precaution to make sure the database is secure and intact. He will create an Internet application with a login interface in which all users need to enter a login ID and password. After SQL 2000 authenticates the user, that user will be allowed to use the database. To prevent unauthorized access after a user has completed a task, if she/he does not logout properly, the application will be terminate after 15 minutes of inactivities.

6. Is the CRC database backed up? How often?

The CRC database is backed up in several ways. Data that is stored on UIC’s ACCC servers are backed up every night. Data on the CRC server is backed up on a weekly basis. For permanent data storage, CRC users may request that their data be copied and stored on CDs.

7. How can I ensure that my database is entered properly?

The Informatics manager can program the application/interface of your our database to “cross check” the data. This can be done in many ways, the best method is immediately after a user clicks the “Submit” button, the application will check the data for rules you have in place. For example, if the application is programmed to accept a research subject ID having a minimum of 4 digits, then if the user enter 3 digits, the user will immediately receive an error message, asking to enter the ID again along with appropriate instruction. To prevent duplicate records, when a user adds a new subject ID to the database, the application can check the database for any existing entries with the same ID number.


Education:

1. When does the CRC offer its education program?

The CRC organizes an introductory course on the Principles of Clinical Research (nine hours presented in three, three-hour blocks

2. Who can participate in the education program activities?

All University of Illinois faculty, staff and students interested in clinical research are welcome to register for the CRC education program activities. Others will be considered if they are affiliated with CRC projects.

3. What is the fee for attending any education program seminars?

All seminars offered through the CRC Education Program are free.

Researh Subject Advocate:

1. What role does the Research Subject Advocate play in the CRC?

The Research Subject Advocate (RSA) program at UIC is a response to an initiative of the NIH's National Center for Research Resources to ensure that all steps are taken to maximize research subject safety. The responsibilities of the RSA and the RSA's staff include the following:

1. Serving as a resource to CRC investigators as they design their study's Data and Safety Monitoring Plan (DSMP) and to the SAC as it reviews the DSMP.
2. Responding to subjects' questions/concerns about the CRC study in which they are participating.
3. Maintaining records documenting that CRC studies' adhere to IRB approved protocols and DSMP's.
4. Facilitating the reporting of Adverse Events.

Administration:

1. I am preparing a report of a study that used UIC’s CRC resources. How do I reference this support?

You must acknowledge CRC support. The following is suggested:
"This work was supported by a grant from the NIH/National Center for Research Resources (Clinical Research Center, M01-RR-13987) to the University of Illinois at Chicago."