Dx Biosamples Specimen Management and Collection Services include:
Project Coordination and Logistics
- Development of collection protocols and Case Report Forms (CRF)
- Development of HIPAA compliant patient Informed Consent Forms (ICF)
- Institutional Review Board (IRB) submissions
- Collection site setup, training and monitoring
- Provision of supplies and equipment
- Project management and logistics coordination
- Monitoring clinical data and reports completion
- Query resolution
- Longitudinal study support: specimen collection from the time of diagnosis throughout treatment cycles and remission
Ethical Specimen Collection
- All prospective specimens are collected under IRB approved protocols from consented donors at medical clinics and hospitals
- Blood specimens, from consented healthy donors, can be acquired from FDA licensed facilities following GMP procedures.
- Retrospective specimens are acquired under an IRB approved protocol with waived informed consent or collected as de-identified remnants during routine medical procedures carried out for patient diagnosis and follow up.
Clinical Data Development
All materials are accompanied by comprehensive clinical data including demographics (age, gender, race), diagnosis, disease stage/activity/progression, disease specific scores and assessments, symptoms, treatments, medications, comorbidities, smoking history, medical history, family history. Cancer stage, grade, TNM, mutation profile (where available) is provided for oncology patients.
- We can provide any clinical data available in the patient chart
- Disease specific scores and assessments
- Follow up data for 3-10 years
Specimen Quality Assurance
All materials have to comply with Dx Biosamples Quality Control Criteria:
- The subjects are recruited strictly by the study inclusion/exclusion criteria
- Written subject informed consent (ICF) is required for all subject participating in the prospective collection studies. The ICF must be signed prior to sample collection. Once signed a copy of an ICF is given to the subject for their records. An original of the signed ICF is stored with the study records at the collection site.
- Sample collection, processing and shipment has to be done following the study protocol
- Each specimen has to be labeled and stored as described in the study protocol
- The data provided with each specimens has to be complete, legible and accurate
- All subject information has to be de-identified
- Tissue specimens are reviewed by Board Certified pathologists to confirm the diagnosis, preservation method and specimen quality and eligibility