How to Request Specimens from the Central Repository

 

Many factors contribute to specimen selection such as the focus of the laboratory assay, serostatus requirements, HAART status, rate of disease progression, and whether progression should be defined clinically or immunologically. Investigators should consider all relevant selection criteria prior to sending sample specifications to WDMAC. 

All specimen requests should be submitted to the WDMAC Project Director, Christine Alden (calden@jhsph.edu).

Requests for specimens will not be processed until the science is approved by the WIHS Executive Committee (EC) and verification of local IRB approval has been granted. Requests should include a completed repository checklist, which can be found on the WIHS Public Website (http://statepiaps.jhsph.edu/wihs/index-invest-info.htm/ReposCheckList.doc). If the investigator has already determined WIHSID-visits, an Excel spreadsheet of WIHSIDs, visits and visit dates should be attached to the request. If the investigator has not yet determined WIHSID-visits, a WDMAC programmer will work with the investigator to select appropriate WIHSID-visits based on the selection criteria in the approved concept sheet. The WIHS Repository Checklist must be filled out in full so the WIHS Project Director can properly process the request and determine if a WIHS Statistical Programmer is needed.

Please note that times from request to shipment may vary depending upon results of QA process, workload at WDMAC and SeraCare, and availability of specimens at SeraCare, but WDMAC strives to submit all requests to the repository within one week of QA completion. SeraCare will ship the specimens within 5 weeks (8 weeks if the specimens need relabeling) of request submission.

REQUEST TO WDMAC
The WIHS Repository Request Checklist includes: 

• The Readme number for the project; 
• Investigator contact and email information;
• Specimen Type;
• Total expected number of specimens;
• Minimum acceptable volume;
• Lab that specimens should be shipped to, including name, address and at least one phone number;
  Freeze/thaw info – preferred method of shipping (dry ice, liquid nitrogen); whether or not pristine specimens are required; if SeraCare should thaw and aliquot;
• Special instructions: Should the repository pack vials for shipment in any particular order? Does the project require blinded/relabeled specimens?  What variables will the testing facility need on the manifest from the repository?  What is an acceptable file format for the manifest so that the testing facility can incorporate the file into their tracking system?
• Signed assurance that the project has local IRB approval.

Fax the completed checklist to Christine Alden at 410-614-7125

RESTRICTIONS ON SAMPLES
When an investigator unknowingly requests the last vial for a WIHSID-visit-specimen, WDMAC will inform the investigator, asking him or her to select alternate visits or WIHSIDs from which another vial may be taken. If this is not possible, the investigator should contact local repositories for the needed specimens. If no alternates are available, then the investigator may request additional review by the WIHS EC to justify the scientific use of those specimens. Only the WIHS EC can approve the release of the last vial of a specimen type, WIHSID, visit unique combination.

The B-cell immortalization program was ended in July of 2004. 60% of WIHS participants have
established B-cell lines (73% of the 94/95 cohort and 29% of the 01/02 cohort). Only cell pellets can be distributed to investigators. Requests for immortalized samples should follow the process described above.

GENERAL GUIDELINES
The WIHS Investigators are providing the specimens with the understanding that the WIHS is entering into a full collaboration with the individual study investigator(s) and that all data generated from the WIHS specimens will be provided to the WIHS EC (or WDMAC) in a timely fashion as outlined below.  Moreover, the data generated from WIHS specimens will remain the property of the WIHS EC, but the study investigator(s) will have exclusive first rights to the publication of these data as outlined below.

All data generated from the WIHS specimens must be submitted to WDMAC at the earliest of the following:

• 1 month following the acceptance of the first paper to be written using the WIHS data.
• 1 year following the receipt of the WIHS specimens by the study investigator.

The deadlines specified above are open to negotiation with the WIHS EC. They may be altered only by the WIHS EC with alternate deadlines being specified in a letter drafted by the WIHS EC and addressed to the study investigator.

To ensure that progress is being made on the testing of WIHS specimens, quarterly updates detailing the status of the testing of the specimens and the preparation of the manuscript must be submitted to the WIHS EC beginning 3 months after the receipt of the specimens by the study investigator.  If the specimens have not been tested within 1 year of receipt, then the specimens must be returned to the WIHS.

REQUIREMENTS OF RESULT DATASET
The results dataset should be sent via email to the WDMAC Data Manager with the WIHS readme number, a brief synopsis of the project and type of testing performed.  Investigators are also responsible for sending a codebook that includes valid result ranges and full test names.  If the results are published at the time of dataset transmission, the investigator should also send a complete citation.

The dataset can be in excel or ASCII format.  At a minimum, the dataset should include the following variables for each record: WIHSID, visit, specimen collection date, specimen testing date, test(s), and result(s).