Initiating a LOCS License

To initiate a LOCS II or LOCS III License, Chylack Inc requires that you provide the following specifics about your study:
  • the name of the intended trial

  • the duration of the intended trial

  • the number of clinical sites involved and their locations

  • the number of doctors needing LOCS training as well as the likely number of subject-visits/month for each (if you can estimate this)

  • the number of doctors participating in your trial who may have previous experience with LOCS

    With this information, Chylack Inc. will provide a LOCS License subscription document including a budget for Certification and Recertification. Specific Sponsor responsibilities are outlined in this document and it is important that these be reviewed carefully and completely.
   Should you wish to proceed, your designee and Dr. Chylack would execute the License, any necessary invoices would be processed, and training could begin. We recommend new, repeat, and potential partners carefully review the terms and requirements of a LOCS III License with the project team in advance of active LOCS training.

Partner Responsibilities
Once the specifics of the License Agreement are established, it is essential that Chylack, Inc. have a web-interactive introductory session with the director of the licensed study and any other individuals responsible for communicating with participants. During this session Chylack, Inc. will review responsibilities for the Licensee and Chylack Inc.

Communication
Individual Authorized Users should address all routine communications to their study or site coordinators.  Chylack, Inc. will not assume responsibility for communicating directly with sites or individual study participants regarding ongoing LOCS III training procedures and results: those communications are to be initiated and maintained by the sponsor.

Tracking and Documenting Results:  
The Licensee is responsible for maintaining accurate records of enrollees’ training progress, testing results, and a schedule of testing deadlines. Chylack Inc. will provide study updates, but will rely on the Licensee to communicate changes or additions to the study’s Authorized User list in a timely fashion.
 
Additional Materials (LOCS Transparency)
In addition to an executed license agreement, you will need to purchase the LOCS III Transparency Standard for each Authorized User.  See Recources.
 
Required Consulting Agreement
To complete the execution of any LOCS License, Dr. Chylack will need to establish a consulting agreement with your company.  Or, any existing consulting agreement that Chylack Incorporated has in place would need to be amended to include the new trial, and extended, if needed, to capture the term of the agreement.

   Charges will be incurred by consultation under the following circumstances:
Often companies direct to Dr. Chylack non-LOCS III-related questions about their protocol. He is happy to answer these but needs a mechanism to bill for this service. If there are no questions, there will be no charges.

    At the end of the protocol many companies ask Dr. Chylack to assist them in the analysis of the LOCS III data. Dr. Chylack does this as a consultant and bills accordingly. If there is no need for this, there will be no charges.

   Occasionally doctors who take the LOCS III training fail a Certifcation or Re-certification test twice. In this circumstance Dr. Chylack may set up a one-on-one web-based, interactive, training session for this doctor to ascertain the areas of difficulty. Dr. Chylack bills for this training session as a consultant. It usually takes 4-5 hours to set up, complete, and report on such a session.

License Inquiry
If you are interested in initiating a license, if you have questions about an active license, or if the terms of your license need to be redefined with an Amendment in anticipation of a change in your protocol, please contact:

Leo T. Chylack, Jr., MD
President

or

Lacey M. Chylack
Financial Officer

Make a license inquiry

  • Reload

Which LOCS should I license?
If after reviewing the descriptions of LOCS II and LOCS III you cannot specify with certainty which system you want to use, please discuss the details of your project with Chylack Inc..

RESOURCES

File

To order the LOCS III Transparency

Download File