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Genomic Nominator Certification Procedure

Introduction

The Genomic Nominator Certification procedure involves a series of steps that applying genomic nominators are required to perform to demonstrate their capability of providing standard, accurate data to CDCB in the required format.
During the certification process, genomic nominator are required to pay an annual fee, produce a series of legal and administrative documentation and prepare and submit a format1G file similarly to already approved genomic nominators. However, each step of the procedure is run manually for the first time.

Certification Process

1. All applying genomic nominators are required to read all the materials available under "GENOMIC NOMINATOR APPLICATION AND CERTIFICATION INFORMATION": https://redmine.uscdcb.com/projects/cdcb-customer-service/wiki#GENOMIC-NOMINATOR-APPLICATION-AND-CERTIFICATION-INFORMATION. In this section you'll find all the required forms, documents and contracts, together with highly useful information about the CDCB standard requirements for genomic nominaotors. If you have questions regarding any of these documents, please contact the CDCB genomics team via email.

2. Download, complete, sign (where applicable) and submit via email to the CDCB genomics team all the required documents listed below:
  • CDCB Genomic Nominators - Application Form, fully compiled and signed. Note this file is provided in Microsoft Word for your convenience. The Application form will be evaluated by the CDCB Staff and an approval (or not) to continue the process will be communicated to the proponent.
    Once the Application form is approved, the proponent is required to produce:
    1. Appointment of personnel who will access the CDCB IT services. In case the Application Form does not cover all the people in the company that will access the CDCB IT infrastructure, the people entitled to gain access to it should be described separately.
    2. Complete Standard Operating Procedures (SOP). The CDCB Genomic Nominators - SOP template format should be followed.
    3. Signed Material License Agreement (MLA). The document is available here: CDCB Genomic Nominators - MLA .
    4. Payment of the CDCB Genomic Nominator application fee ($1000) - Note instructions and details about this payment will be received by the applicant once the Application Form is approved.

3. Once all documentation is produced and verified, CDCB staff will generate and share detailed information about the new account and connection details (username, password, protocols, folder structure).

4. The proponent will indicate the/a collaborating laboratory to nominate the samples being tested in the certification process. CDCB requires real data to be submitted for this purpose.

5. Provide CDCB (format1G file) that contains minimum of 20 nominations in specified SFTP directory. (Guideline available at https://redmine.uscdcb.com/attachments/download/1249/CDCB%20Genomic%20Nominators%20-%20Navigation%20guide.pdf)
  • The CDCB staff will verify file formats and quality of the data provided.

6. The Nominator must successfully conclude the approval process within 2 months from the application date; otherwise, the Nominator will have to reapply and restart the process.

7. The CDCB will start the automation process once the successful format1G submission is confirmed. Once automated system process the applicant's format1G, a notify file will be generated in "out" directory.
8. Once both applicant and CDCB confirm that nominations were accepted, the certification process is complete, the CDCB staff will guide the applicant in the use of online queries.

9. Once the certification process is complete, the CDCB Genomic Nominator annual fee must be paid for the Nominator to begin operating regularly

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