ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research ALLG Leukaemia and Lymphoma Discovery Centre Biobanking for blood cancer Appendix B Application for Tissue Samples 1. INVESTIGATOR INFORMATION Investigator name: (include title) Investigator contact details Current position or appointment: Institution: Address: Email: Telephone: Investigator CV. Please insert a short CV which includes your professional education, research and professional experience and peer-reviewed publications published in the last 5 years. 2. TISSUE SAMPLE REQUEST Have you contacted the ALLG Discovery Centre staff to confirm sample numbers for your project are available? Yes No. Please contact Megan Ellis, ALLG Tissue Bank Manager Ph: (07) 3176 5835 Email: megan_ellis@health.qld.gov.au Describe the samples you are requesting from the ALLG Discovery Centre. Add more boxes as required. Sample request 1. WHO Classification: Tissue source: Sample type: (RNA, DNA, serum etc.) 1 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research Volume: Quantity: Please provide sample number calculations to justify the number of samples requested (if applicable). Sample request 2. WHO Classification: Tissue source: Sample type: (RNA, DNA, serum etc.) Volume: Quantity: Please provide sample number calculations to justify the number of samples requested (if applicable). Sample request 3. WHO Classification: Tissue source: Sample type: (RNA, DNA, serum etc.) Volume: Quantity: Please provide sample number calculations to justify the number of samples requested (if applicable). Sample request 4. WHO Classification: Tissue source: Sample type: (RNA, DNA, serum etc.) 2 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research Volume: Quantity: Please provide sample number calculations to justify the number of samples requested (if applicable). 3. REQUESTS TO OTHER TISSUE and BIO BANKS The ALLG Discovery Centre receives samples from numerous Australian institutions. To prevent issue of duplicate samples, we ask investigators to disclose requests to other Bio Banks for this project. Have you applied or will you be applying for samples from any other Tissue or Bio Banks for this project? Yes (provide details below) No Tissue Bank name: Samples requested: Tissue Bank name: Samples requested: Tissue Bank name: Samples requested: 4. SAMPLE LOGISTICS Sample delivery information Name of contact person for delivery: Contact person phone number: Days of week and hours of operation available for courier delivery: Exact delivery address to be used by courier: 3 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research Would you like the ALLG to organise sample transport on your behalf? Yes (ALLG will organise dispatch, initially pay courier costs and then invoice researcher for reimbursement of the transport costs when invoicing for sample cost recovery) No (The organisation and cost of sample transport will be the responsibility of the researcher. Confirmation of dispatch dates with ALLG staff must be organised by the researcher prior to booking couriers) 5. PROJECT INFORMATION Project details Title of proposed project: Anticipated project commencement date: Anticipated project completion date: Location where project will be undertaken: Approvals Funding status of the project Do you have Institutional support to undertake this project? Yes (ensure Section 7 is completed) No – Institutional support is required for issue of samples of the Discovery Centre Do you have Ethics Committee approval to undertake this project? Yes (attach Ethics Committee approval letter) No – Ethics Committee approval is required for issue of samples What is the funding status of this project? Provide details of any secured or pending funding for this project: Fully funded Pending grant application NHMRC grant Application ID: _________ other grant* internal funding/grant* other* *Provide details below Please attach approval letter(s) for secured funding/grant(s) for this project. 4 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research Funding details and comments: Project description. Please provide a description of the project that will be undertaken. Include background, rationale, methods and references. 5 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research 6. CONDITIONS OF USE OF TISSUE BANK SAMPLES Appendix C Please read the following information and complete Section 7. Samples from the ALLG Discovery Centre are provided with the intention of facilitating research into haematologic malignancies. The samples must be used in the manner described in this application. Any change in the project direction must be communicated in writing to the ALLG Discovery Centre Manager and Director which reserves the right to withdraw support. Samples must not be given or sold to other investigators. The samples provided to researchers are de-identified. No attempts should be made by the Investigator to identify the patient or to determine other patient information. If additional information is required, it should be requested through the Discovery Centre Manager who will forward the request to the relevant ALLG committee. Clinical data can be retrieved from the ALLG trial centre when pertinent to the interpretation of the research. There may be a charge associated with the retrieval of clinical data. The tissue provided is as far as possible representative of the entity requested. However, diagnostic verification has not been undertaken in all cases. The ALLG accept no responsibility for the inadvertent provision of incorrect tissue. In addition, while every effort is made to provide high quality material, sample transport prior to storage is an uncontrolled variable which may interfere with sample quality. Although every attempt is made to preserve the quality of the samples, the ALLG cannot guarantee that mRNA will be obtained from samples. While samples are not stored from patients with known HIV, Hepatitis B or Hepatitis C, the screening of patients for the presence of such pathogens is not routine. Standard precautions for the handling of human tissue and fluid as recommended by the Australian National Health and Medical Research Council (NHMRC) should be used in all cases to prevent infection with any pathogens present. No responsibility will be taken by the ALLG for injury or illness that may occur to staff handling the samples. There may be a cost recovery charge for the provision of specimens depending on funding arrangements. The costs of packaging and transport of the specimens will be borne by the individual requesting the samples. The Investigator(s) is required to provide a 12 month report which summarises the progress of the research and outlines the use and usefulness of the supplied samples, whether the study is ongoing and the anticipated date of study completion. This is to be submitted by the end of December. You will not be asked to reveal the results of the study in this report. At study completion, any remaining samples should be returned for use by others. Depending upon the level of contribution of the ALLG to the project, the Investigator will be required to either (i) acknowledge the ALLG in any publications or presentations resulting from the work; or (ii) enter into collaboration with the appropriate ALLG member(s) who will be recognised as a co-author on any publications resulting from the work. The type of recognition required will be decided on a case by case basis at the time of application approval and throughout the project. Failure to recognise the ALLG in the manner decided by the Committee will render the individual and/or the institution ineligible for future applications. 6 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research Copies of any publications arising from the use of ALLG Discovery Centre samples should be forwarded to the Discovery Centre Manager who will then notify the relevant ALLG committee. Samples will not be provided until a signed copy of the Agreement (Section 7 below) has been received. 7 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research 7. AGREEMENT FOR ALLG DISCOVERY CENTRE SAMPLE USE Appendix D I, ____________________________________ (print name) have read, understood, and agree with the ‘Conditions of Use of ALLG Discovery Centre Samples’ (Section 6 above). I additionally agree to the following: 1. 2. 3. 4. 5. 6. That I will use the specimens provided to me by the Discovery Centre only in the manner detailed in my application for these specimens. I will not give or sell them to a third party or use them for any purpose not specified in the application without prior specific approval. That I will not, in any way, attempt to identify the patients from whom these samples were obtained, nor will I attempt to gain any personal information regarding these patients other than that obtained through the Discovery Centre. Clinical information pertaining to these patients and pertinent for my research may be requested through the ALLG Discovery Centre Manager where the request will be forwarded to the relevant ALLG committee. A cost recovery fee will likely apply for retrieval of clinical data. I realise that these samples have not been screened for potential pathogens and therefore may result in severe illness or even death if not handled properly. The responsibility for the correct handling of the samples lies solely in my hands and is not the responsibility of the ALLG. Any illness resulting from the mishandling of these samples is not the responsibility or liability of the ALLG. I will acknowledge the ALLG in any publications or presentations resulting from work on the samples provided. ALLG collaborators will be recognised as co-authors on any publications. Wording of acknowledgment will be in the form of: “We would like to acknowledge the Australasian Leukaemia and Lymphoma Group Discovery Centre for the provision of haematologic malignancy samples for this project. The ALLG Discovery Centre is supported by The Leukaemia Foundation of Australia funding.” I agree to provide brief reports to the ALLG on a 12 monthly basis. Signature of Investigator: Full name (printed): 7. ________________________Date:___________ ___________________________________________ I, the undersigned as Institutional Head, have the authority to execute this agreement on behalf of the institution detailed below. Signature of Institution Head: ___________________________________________ Full name (printed): ___________________________________________ Institution Name: ___________________________________________ Institution Address: ___________________________________________ ___________________________________________ 8 ALLG Discovery Centre Princess Alexandra Hospital c/- Haematology/Pathology Main Building Level 1 Ipswich Road Woolloongabba QLD 4102 www.allg.org.au Improving the treatment and the lives of patients with blood cancers through clinical trial research 8. CHECKLIST Completed application form Institutional funds are available Approval letter(s) for secured funding/grant(s) attached Ethics Committee approval letter attached Section 7 Agreement for Sample Use completed and signed 9. HOW TO SUBMIT THE APPLICATION FORM Email a scanned copy of the application form to: Megan Ellis ALLG Discovery Centre Manager Email: megan_ellis@health.qld.gov.au Please type in subject line: ‘ALLG Researcher Application for review’ OR Mail the application form to: Megan Ellis ALLG Discovery Centre Manager c/- Haematology/Pathology Princess Alexandra Hospital Main building, Level 1 199 Ipswich Road Woolloongabba Queensland AUSTRALIA 4102 9