Protocol Questions
Issue: Eligibility
Procedure: Look at protocol/MOO; ask PI.

Issue: Medical questions
Procedure: Look at protocol/MOO; ask PI or physician.

Issue: Concurrent medications
Procedure: Look at concurrent medication list; ask PI or physician.

Issue: Post-randomization questions
Procedure: Ask PI.

Issue: Questions that cannot be answered locally
Procedure: Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu
or Marston Youngblood at 919-962-3083 or myoungblood@mail.cscc.unc.edu.
Comments: If you contact Kelly or Marston and leave a message, and later contact the other
one who is able to answer the question, please notify the person initially contacted via
phone or email to let them know that the issue has been resolved.

Issue: MM questions
Procedure: Look in MM manual; ask MM supervisor.
Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: CBI questions
Procedure: Look in CBI manual; ask CBI supervisor.
Contact Lisa Arciniega at 505-768-0264 or lisata@unm.edu.


Randomization
Issue: Randomizing an individual
Procedure: Call the Voice Randomization System (VRS) at 1-800-472-2595.

Issue: The VRS is not working
Procedure: Contact Marston Youngblood at 919-962-3083 or myoungblood@mail.cscc.unc.edu.

Issue: When can a participant be derandomized?
Procedure: Look at derandomization in the MOO.

Issue: How do I derandomize someone?
Procedure: Look at derandomization procedures in the MOO.


Laboratory Issues
Issue: Protocol questions
Procedure: Look in the Quintiles manual.

Issue: Questions that cannot be answered by reading the lab manual
Procedure: Contact Marston Youngblood at 919-962-3083 or myoungblood@mail.cscc.unc.edu.

Issue: Ordering lab kits
Procedure: Fax request form in Quintiles Manual to Quintiles.

Issue: Questions about the lab reports
Procedure: Call Quintiles at 800-676-8452.

Issue: Change in contact information, need reports faxed to different person/number
Procedure: Contact Marston Youngblood at 919-962-3083 or myoungblood@mail.cscc.unc.edu.

Issue: Questions about IATA training
Procedure: Look at IATA letter from Quintiles and IATA training guidelines.


Clinical Care Issues
Issue: Clinical care questions
Procedure: See clinical care guidelines.

Issue: Breaking the blind
Procedure: See Guidelines for Breaking the Blind.

Issue: Need further consultation (non-emergency)
Procedure: Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: Need further consultation (urgent)
Procedure: Contact your site's Clinical Care representative.


Serious Adverse Event (SAE)
Issue: Unsure if event is serious
Procedure: Read definition of SAE and talk to PI.

Issue: Reporting SAEs and entering data into COMBINE DMS
Procedure: Call Anita Goodman at Lipha immediately at 978-542-1904 or Craig McMillan at 210-536-1730 or 917-562-5574(cell).
Fax Lipha SAE form and COMBINE SAE form to Lipha within 24 hours, Attn.: Craig McMillan or
Anita Goodman, at 978-542-1950.
Fax COMBINE SAE form to Kelly Tobin at the CC within 24 hours at 919-962-3265.
Fax COMBINE SAE form to Dr. Raye Litten at NIAAA within 24 hours at 301-443-8774.


Medications and VA Pharmacy
Issue: Ordering medication
Procedure: Call the Pharmacy Coordinating Center (PCC) at 866-228-0256.
See section in the MOO for more information.

Issue: Problem with ordering medication
Procedure: Call the PCC at 505-248-3203.

Issue: Problem with ordering medication and no one is available at the PCC
Procedure: Contact Marston Youngblood at 919-962-3083 or myoungblood@mail.cscc.unc.edu
or Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: Disposal of unused medication
Procedure: See section in the MOO.

Issue: Problem receiving study drug confirmation fax
Procedure: Call Kathy Boardman at 505-248-3203.


Certification Issues
Issue: Medical management certification
Procedure: See guidelines for MM certification and monitoring center procedures.
Contact Denise Ernst at 505-768-0261 or dernst@unm.edu.

Issue: CBI certification
Procedure: See guidelines for CBI certification and monitoring center procedures.
Contact Lisa Arciniega at 505-768-0264 or lisata@unm.edu.

Issue: Form 90 certification
Procedure: See guidelines for Form 90 certification.
Contact Roberta Chavez at 505-768-0134 or robertac@unm.edu.


Personnel
Issue: Obtaining a staff ID and PIN
Procedure: Forward the contact information and title of the new staff member to Kelly Tobin
at kelly_tobin@unc.edu. Inform her of whether the staff member will be calling the VRS
and/or ordering medications from the VA.

Issue: Change in personnel
Procedure: Contact Kelly Tobin at kelly_tobin@unc.edu.

Issue: New research pharmacist
Procedure: Email the pharmacist's name and contact information (address, phone, fax, email)
to Kelly Tobin at kelly_tobin@unc.edu and to Laura Kendall at Laura.Kendall@csp.research.med.va.gov.


Site Visits
Issue: Scheduling
Procedure: Contact Lipha site monitor.

Issue: Questions
Procedure: Contact Craig McMillan at 210-536-1730 or 917-562-5574(cell) or cmcmillan@emindustries.com.


Data Management
Issue: Functions of the DMS
Procedure: Look in DMS manual.
Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: Questions about data entry
Procedure: See data entry guidelines.
Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: Data transfer schedule
Procedure: See 2003 data transfer schedule.

Issue: Problem with data transfer
Procedure: See instructions for data transfer.
Contact Bob Sumner at 919-966-9592 or uccrgs@mail.cscc.unc.edu.

Issue: Problem with DMS
Procedure: Contact Bob Sumner at 919-966-9592 or uccrgs@mail.cscc.unc.edu.

Issue: Shipping data diskettes or forms
Procedure: Send to the CC at:
COMBINE Central Receiving
Collaborative Studies Coordinating Center
The University of North Carolina at Chapel Hill
137 E Franklin Street, Suite 203
Chapel Hill, NC 27514-4145

Issue: Client Tracking Database Access-related questions
Procedure: See CTDB guidelines.
Contact CTDB manager at your site or use the help menu.

Issue: Client Tracking Database database-related questions
Procedure: See CTDB guidelines.
Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.


Protocol Violations
Issue: Unsure about whether an event is a protocol violation
Procedure: Review protocol violation list.
Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: Where to document violations and deviations
Procedure: Use protocol violation log.

Issue: Use of uncertified clinicians/therapists
Procedure: Contact Kelly Tobin in real time via email at kelly_tobin@unc.edu, and document on
protocol violation log.


Assessments
Issue: Request for more case report forms (CRFs)
Procedure: Contact Kelly Tobin at 919-966-7825 or Suzanne Martin at 919-966-6376 when you
have eight to ten packets left. (The CC needs two weeks to get CRFs printed and sent out.)

Issue: Do I have the correct versions of the CRFs?
Procedure: Check list of main trial CRF versions.

Issue: How do I enter a specific form into the DMS?
Procedure: Review the data collection and entry guidelines for specific CRFs.

Issue: Form 90 questions
Procedure: See Form 90 manual.
Contact Roberta Chavez at 505-768-0134 or robertac@unm.edu.

Issue: Need BACCUS
Procedure: Download from: http://casaa.unm.edu/dload.html.

Issue: Need another computerized SCID screen
Procedure: If your center has a satellite site, the CC will provide another copy of the
software. Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.
If your site does not have a satellite site, your site will need to purchase a copy.
Go to: www.mhs.com, select "Purchase", then enter "SCID II Expert System" in the Search area.


Regulatory Issues
Issue: Wording of consent forms
Procedure: Ask PI or IRB.

Issue: Questions about request for a Certificate of Confidentiality
Procedure: Contact Susan Farrell at 301-443-1274 or sfarrell@willco.niaaa.nih.gov.


Ancillary Studies
Issue: Questions about administration of forms
Procedure: Look at assessment administration table.

Issue: Specific questions about protocol
Procedure: Look at ancillary study protocol.
Contact a PI involved in developing the study if the protocol does not answer your question.


Mailings
Issue: Did not receive package that was sent out by CC
Procedure: Contact Suzanne Martin at 919-966-6376 or uccslf@mail.cscc.unc.edu
or Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu.

Issue: When did you send that document?
Procedure: See memos log.


Miscellaneous

Issue: Need web site user name and password or CTDB password
Procedure: Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu
or Suzanne Martin at 919-966-6376 or uccslf@mail.cscc.unc.edu.

Issue: Conference call day and times
Procedure: Look at web site calendar.

Issue: Request for more AA brochures
Procedure: Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu
or Suzanne Martin at 919-966-6376 or uccslf@mail.cscc.unc.edu.

Issue: Request for more Emergency Medication cards
Procedure: Contact Kelly Tobin at 919-966-7825 or kelly_tobin@unc.edu
or Suzanne Martin at 919-966-6376 or uccslf@mail.cscc.unc.edu.

Issue: Where should session tapes be sent to?
Procedure: Send tapes to UNM at:
University of New Mexico
Center on Alcoholism, Substance Abuse & Addictions (CASAA)
2650 Yale Blvd. SE
Albuquerque, NM 87106