CALGB Tissue Bank General Policies:

A CALGB tissue bank can be established following approval by the Solid Tumor Correlative Science Committee, Leukemia Correlative Science Committee or Pathology Committee as well as the Executive Committee of CALGB and must adhere to the policies and procedures of the CALGB. As a responsible guardian of specimens for the CALGB and the nation, each bank must have safeguards in place to address medical-legal, confidentiality and privacy concerns of the patient, the submitting pathologist or other physician and the institution submitting the specimen.

These policies include the following:

• Samples can only be obtained from patients who are registered to a CALGB study (clinical trial study or a laboratory companion study).
• As the CALGB guardian of these samples, the tissue bank director agrees that these samples are the property of the CALGB and as such will procure, store, process and distribute the samples according to CALGB policy. In addition, if the bank does not comply with CALGB policy, CALGB can and will move the bank and transfer samples to another approved CALGB location.
• Samples cannot be distributed to any investigator without prior approval of the scientific proposal from the appropriate CALGB scientific committee and, when necessary, the Executive Committee. Approval of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute may also be required for some studies.
• If for any reason a patient/participant in a study decides that they do not want their sample to remain in the bank, their samples will be disposed of appropriately-either destroyed or, in the case of paraffin blocks, returned to the submitting institution.
• For tissue blocks/sections that have been submitted, quality control slides (H & E stained sections, touch preps or imprints) will be prepared and remain on file at the CALGB PCO and will be available to the submitting institution for any medical - legal need. In the case of whole blocks, any material remaining in the block will be returned to the submitting institution for any medical-legal need.
• Only CALGB members can establish and maintain a bank for CALGB. If the member investigator moves to a non-CALGB institution, the bank of samples will be transferred to an appropriate CALGB investigator who will then take over the banking responsibilities of those samples.
• All samples collected, processed, banked and distributed will be managed using the customized LabTrak database developed by the CALGB Statistical Center.
• To protect patient confidentiality and privacy, samples distributed to investigators do not contain any identifiable patient information, only the unique CALGB sample number is contained on the label of the sample to be stored and/or distributed. This sample number is generated by the CALGB LabTrak system. Only select approved CALGB personnel in the CALGB Statistical Center have the ability to match the sample number with clinical outcome information.
• Individual results/data from any correlative science study will NOT be disclosed to the patient/participant or physician unless the results are necessary for eligibility/randomization on a CALGB clinical trial. In this way, clinical decisions/patient management will not be made based on results from CALGB correlative science studies. Aggregate data in the form of abstracts, manuscripts will be available to the patient or physician upon request.
• Each CALGB tissue bank is designed according to the repository guardian model. In this model, as the CALGB guardian for the tissues, the repository provides the link between the patient, their sample and the submitting institution’s clinicians and/or pathologists, ensuring that appropriate policies and procedures are in place to address patient privacy, confidentiality and medical -legal concerns. The guardian also provides the link between the sample used in a STCS laboratory study and the CALGB investigator. These links are monitored by the CALGB Statistical Center and Central Office.
• Collection of specimens for an individual study, not occurring at a main repository, will follow the same policy and procedures as established for repositories (1-10 above). Remaining samples/aliquots not utilized in the study will be sent to the appropriate CALGB repository upon completion of the study. Investigators collecting such specimens must agree to these policies and procedures in writing prior to sample collection. (This includes frozen specimens, specimens embedded in paraffin on site; extracted DNA, RNA, unstained sections, etc).
• Oversight for appropriate compliance for repositories, main and individual, will be a function of the appropriate scientific committee of CALGB and the CALGB Group Chair.

The Cancer and Leukemia Group B as well as the other NCI-sponsored cooperative groups maintain repositories of tissues collected from patients who are uniformly staged and treated and for whom long term clinical outcomes are available. As such, these repositories are of enormous value in supporting correlative science studies that relate molecular markers to clinical outcomes for purposes of predicting the prognosis of patients and the likelihood of response to specific therapies. Although the cooperative group tissue banks are national resources, access to specimens must be carefully controlled so that these unique and well characterized specimens are used in support of only the most meritorious research that has a high probability of producing definitive results. Investigators with an interest in obtaining CALGB specimens are encouraged to contact the representatives of the appropriate tissue repository described herein.