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CHOP BIOBANKING PRINCIPLES – PLEASE READ

Sample Collection and Storage

All human samples collected for Biobanking as part of this Study/Project must be accessioned into the Biobank system following procedures established or reviewed by the BioRC Operational Committee.

o The investigator/study team must provide, when possible, relevant sample information such as:

Pathologic process and details (e.g., percent tumor, necrosis, flow data)

Relevant clinical data (age, gender, treatment, etc.) Collection date and method, processing date and methods,

deviations.

o The BioRC will provide resources to help design the project in order to assure best practices are followed.

All human tissues collected through Pathology as part of this Study/Project will be directly released to the BioRC for storage.

o Exceptions: Investigators may request exceptions and store samples elsewhere, but this must be approved by the BioRC Oversight Committee

o Storage external to BioRC will follow procedures developed by the collecting investigator/team, but this will be reviewed by the BioRC Oversight Committee to insure that all tissues are collected, processed and stored using best practices.

Sample Collection and Storage

The Investigator will decide prior to collection if samples are to be made available immediately to others or should be protected. Samples collected, stored and funded by external sources can be protected indefinitely as long as specimen distribution is managed following best practices.

o After the period of protection ends, the specimen becomes available to others pending review by the BioRC Oversight Committee.

Prior to distributing formerly protected specimens, the BioRC Oversight Committee will obtain input from the investigator or

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investigative team regarding decisions on distribution. However, the decisions on distribution are the responsibility of the BioRC Oversight Committee.

Exception: The BioRC Oversight Committee may delegate distribution responsibilities to investigative teams that have developed policies and practices that adhere to the principles established by the Institutional Biobanking Committee (IBC).

Any sample and associated data may be distributed upon request by the original collecting investigator/team.

Sample Data

Specimen, clinical, and derived data about the banked samples will be made available to all investigators through a centralized portal (Arcus).

o De-identification will be achieved by an eHonest Broker system.

o Accessioning information is automatically made available to all investigators and protected samples will be electronically flagged.

o Generalizable data (e.g. “omics” data) must come back to a central repository (after a certain grace period for publication).

o Other derived data (e.g., specific expression studies, response to specific drugs, etc.) should/must be made available to CHOP researchers (after a certain grace period for publication).

Operational

The IBC will encourage distribution of samples rather than provide obstacles to obtaining samples

o Barriers to obtaining samples will be low

o The BioRC Oversight Committee will approach proposals with the intent to distribute rather than restrict access

o Rejection of sample requests will require detailed reasoning, suggestions for improvement of application, and can be appealed.

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PLEASE FILL OUT INFORMATION AND EMAIL TO: BIORC@EMAIL.CHOP.EDU

SECTION 1: STUDY INFORMATION

Please enter the requested information regarding the Study:

PI Name, Division/Center

Study Title

IRB#(s)

Date collection/study started or will start

Click here to enter a date.

Date collection/study ended or will end

Click here to enter a date.

Study Contacts (Name, Role, email, phone)

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SECTION 2: STUDY/PROJECT DESCRIPTION

Briefly describe the study/project or provide a study abstract.Please describe the research value of the samples (existing or prospective) for Researchers at CHOP.

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Type of Project/Request- Is this a ….?

New Biobanking Project - BioRC Supported/Managed Fill out Section 3

Transfer of an Existing Biobank - BioRC Managed Fill Out Section 4

Externally Managed Biobank Fill Out Section 5

All Biobanking Resource Requests Fill Out:

o Section 6 regarding Consent

o Section 7 regarding Data

Note - All biobanking and storage will need to be tracked and labeled via Nautilus LIMS. All samples managed by BioRC will be stored in the Repository Facility in A420 Colket Translational Research Building.

Briefly describe the study/project or provide a study abstract.Please describe the research value of the samples (existing or prospective) for Researchers at CHOP.

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SECTION 3: INITIATION OF A NEW BIOBANKING PROJECT

SAMPLE COLLECTION

Will the samples be collected from only CHOP subjects (internal) or are there external collection sites?

☐ Internal Collection Only

☐ External Sites

Please summarize the collection protocol (e.g., Two 6ml EDTA Blood tubes from 500 subjects, one will be processed into 3 plasma aliquots, one will be used for DNA extraction. Tissue from surgery will also be collected, samples will be shipped to CHOP, etc.).

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SECTION 3: INITIATION OF A NEW BIOBANKING PROJECT (CONT.)

SAMPLE PROCESSING

Will you need BioRC provide sample processing prior to storage?YES☐ NO☐

BioRC supports the following types of specimen processing prior to storage:

Centrifugation of blood for banking of serum or plasma. Isolation of buffy coat for DNA extraction. DNA extraction from blood, saliva. Dual DNA/RNA extraction from frozen tissue, FFPE. Centrifugation of other biofluids.

(Please note that there will be costs associated with specimen processing).

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SECTION 3: INITIATION OF A NEW BIOBANKING PROJECT (CONT.)

SAMPLE STORAGE INFORMATION

Below are listed BioRC standard storage temperatures and preferred sample size. Please list any storage temperature requirement for your study that differs from the standard conditions below.

Sample Type Storage Temperature

Preferred Sample Size

Whole Blood -80oC 0.4-1ml

Buffy Coat (for DNA Extraction)

-80oC 0.25-0.5ml

Ficoll Pellet (for DNA Extraction)

-80oC 0.4-1.0ml

Serum/Plasma -196oC LN2 Vapor 0.25-0.5ml

Isolated PBMCs -196oC LN2 Vapor 1.0ml

Flash Frozen Tissue -196oC LN2 Vapor 100 -200 mg

Tissue in Freezing Media -196oC LN2 Vapor 1.0ml

Tissue embedded in OCT -196oC LN2 Vapor

FFPE Tissue Room Temp

FFPE Slides Room Temp

DNA -80oC or -20oC 100-400ul

RNA -80oC 80-120ul

CSF -196oC LN2 Vapor 0.25-0.5ml

Cells -196oC LN2 Vapor 1.0ml

Cell Lines -196oC LN2 Vapor 1.0ml

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SECTION 4: TRANSFER OF AN EXISTING/LEGACY BIOBANK COLLECTION TO BIORC

(Please fill out this section if you wish to transfer an existing specimen collection to BioRC).Existing/Legacy Collections: Sample Value for Research, Governance, Accessibility, and Usage

Please briefly answer the following:Describe the Research Value of the samples.How are/will sample requests be vetted (e.g., scientific committee/PI)? Who has access to make requests (e.g., Divisional Researchers)?What is the estimated frequency of sample usage/distribution?

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SECTION 4: TRANSFER OF AN EXISTING/LEGACY BIOBANK COLLECTION TO BIORC (CONT.)

SAMPLE INFORMATION

Please list Current Sample Types, Approximate Numbers, Storage Formats, Storage Temps, and approximate Storage Times. Please describe how the samples were collected and processed or provide the collection and processing SOPs.

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SECTION 4: TRANSFER OF AN EXISTING/LEGACY BIOBANK COLLECTION TO BIORC (CONT.)

SPECIMEN LABELING AND DATA

Are the samples currently tracked/labeled through the Nautilus LIMS system? YES☐ NO☐

If NO, Please answer the questions below.

What system are the samples currently tracked in (e.g., Excel, Microsoft Access, FileMaker Pro)

What specimen data is available (e.g., concentrations, cell counts, viability, volumes/weights, etc.)?

o Label format (e.g., handwritten, printed, barcoded)o Label Information:

Please describe how the information on the label provides sample identification (e.g., unique barcode, unique identifier, subject name, dates, etc.). If unique identifier or barcode-please describe ID structure (unique number, number-letter combo, name+DOB, etc.).

Please describe the types of sample information on the labels (sample type, volume, concentration, etc.).

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SECTION 4: TRANSFER OF AN EXISTING/LEGACY BIOBANK COLLECTION TO BIORC (CONT.)

PROSPECTIVE SAMPLES

Will BioRC will receive additional samples as part of ongoing collection activities? YES☐ NO☐

If yes, list sample types, approximate numbers per month or week, and any sample processing requirements that would be needed.

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SECTION 4: TRANSFER OF AN EXISTING/LEGACY BIOBANK COLLECTION TO BIORC (CONT.)

SAMPLE STORAGE INFORMATION

Below are listed BioRC standard storage temperatures and preferred sample size. Please list any storage temperature requirement for your study that differs from the standard conditions below.

Sample Type Storage Temperature Preferred Sample Size

Whole Blood -80oC 0.4-1ml

Buffy Coat (for DNA Extraction)

-80oC 0.25-0.5ml

Ficoll Pellet (for DNA Extraction)

-80oC 0.4-1.0ml

Serum/Plasma -196oC LN2 Vapor 0.25-0.5ml

Isolated PBMCs -196oC LN2 Vapor 1.0ml

Flash Frozen Tissue -196oC LN2 Vapor 100 -200 mg

Tissue in Freezing Media -196oC LN2 Vapor 1.0ml

Tissue embedded in OCT -196oC LN2 Vapor

FFPE Tissue Room Temp

FFPE Slides Room Temp

DNA -80oC or -20oC 100-400ul

RNA -80oC 80-120ul

CSF -196oC LN2 Vapor 0.25-0.5ml

Cells -196oC LN2 Vapor 1.0ml

Cell Lines -196oC LN2 Vapor 1.0ml

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SECTION 5: INVESTIGATOR MANAGED COLLECTIONS

JUSTIFICATION

Please provide a brief justification as to why the biobank collection will be managed and stored by the Investigator or a Research Group or Center.

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SECTION 5: INVESTIGATOR MANAGED COLLECTIONS (CONT.)

SAMPLE ACCESSION

If you are intending to manage the collection within your lab, samples will need to be accessioned into the BioRC LIMS (Nautilus) and a subject record will need to be created in the BioPortal so that relevant data (e.g., phenotypic, diagnostic) can be linked and the data (sample & subject) can be displayed and queried through the Institutional Biobanking Portal (to be created).

Please indicate below the type of integration you are requesting.

☐ Level 1: Investigator provides periodic electronic sample manifests for upload. The Investigator/Research Team would provide periodic sample manifests with sample types and numbers collected, and internal sample and subject IDs to be uploaded into Nautilus and the BioPortal. Samples are linked via the Investigator provided internal IDs.

☐ Level 2: BioRC supplies barcoded labels and/or tubes and subject IDs. The Investigator/Research Team utilizes the labels, tubes, and subject IDs for sample collection and provides a periodic manifest for upload to Nautilus and the BioPortal as in Level 1.

☐ Level 3: Integration of LIMS within the Investigator’s laboratory. Nautilus LIMS is requested to be installed in the Investigator’s lab to be used to track sample accessioning, processing and storage. Subject IDs from nautilus are

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SECTION 5: INVESTIGATOR MANAGED COLLECTIONS (CONT.)

SAMPLE COLLECTION/PROCESSING/STORAGE

Please describe the types of samples being or that will be collected and provide any relevant collection and processing procedures/SOPs.

Please provide the sample storage conditions.

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SECTION 6: CONSENT INFORMATION

Please provide examples of all relevant consent forms for both prospective and retrospective collection.

Please describe here or indicate on the examples provided the relevant consent information regarding future use of the samples for research.

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SECTION 7: ASSOCIATED DATA

Please describe the types of associated data that is or will be available for these specimens (e.g., phenotypic, clinical, DNA sequence, etc).

Please describe the how that data is currently stored (e.g., excel, RedCAP, other db).

Is the data in a de-identified format?

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