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mXVfcYLEi5ednLqHSFiGNgLjq9z

GCRC Biorepository Request Form

Returning?

A A A

The Georgia CTSA Clinical Research Center at Emory has a Biorepository that includes an array of infectious disease samples.

Our goal is to provide de-identified samples to investigators validating or developing diagnostics and therapeutics in an effort to improve the understanding of the effects, response, and mechanism of a variety of infectious disease samples including SARS-COV-2 and its variants. For general information click here

Please note that this application is for BIOREPOSITORY REQUESTS ONLY. In order for applications to be processed, the study protocol must be submitted at the time of completion of the application. Please direct any questions to gcrc@emory.edu

Do any of these apply to you?

- Will the results of the specimen analysis be published?

- Will the results of the specimen analysis be disclosed outside of your laboratory, such as in a presentation in a scientific lecture?

- Will you maintain records of the specimen analysis to be used in later studies?

- Are the samples being collected for any purpose other than validation of a laboratory test?

- Will these samples be used for any type of genetic sequencing?

* must provide value

Yes

Yes

Yes

Yes

Yes

If the answer to any question above is "yes" the study must be reported to Emory’s IRB located here. The IRB protocol is required before any specimens can be distributed.

If you do not have an approved IRB protocol and would like to see an example of IRB language requesting Biorepository samples, please see the attachment below.

Attachment:

Emory_IRB_Template-Protocol-Registry-Database-Repository.docx

Yes

reset

Please note: To facilitate the transfer of biological material between collaborators at different Institutions, a Material Transfer Agreement (MTA) is required and must be attached within this submission.

After the Recipient Scientist review and approve the budget provided by the Georgia CTSA Clinical Research Centers Biorepository, the MTA procedures found below will be initiated. Emory University standard MTA agreement can be found here

MTA Procedures

Step 1: The Recipient Scientist and their Institution will review the budget proposal and MTA. If in agreeance, please e-mail the signed MTA to the GCRC Business Manager at sherrionda.grady@emoryhealthcare.org and gcrc@emory.edu

Step 2: The MTA will be logged for tracking purposes and routed to the appropriate contract office.

Step 3: Emory's OTT department will review and negotiate the terms and conditions of the agreement as needed and obtain all authorized signatures.

Final Step: Transfer of material occurs upon execution of agreement.

Expand

Yes

reset

Expand

Investigator-initiated

Industry

NIH

Other federal agency

Foundation

Other

reset

Definition of de-identified Biospecimens and/or Data does not contain PHI and must obtain IRB exemption status or expedited approval from the Emory IRB. If you are seeking to obtain de-identifiable specimens, you need to apply for an exemption status from the IRB and include it in your IRB application for reference.

If you need help on your IRB application, please visit: https://www.irb.emory.edu/members/index.html

For additional information regarding office hours, please visit: http://www.irb.emory.edu/about/index.html

For more information regarding IRB guidance for exemption, please see: http://www.irb.emory.edu/index.html

COVID-19

Ebola Convalescent

Flu

HPV

Other

NP Residuals

Bronchoalveolar Lavage (BAL)

Anterior Nasal

How many NP Residual COVID-19 samples do you need?

Total Number	Positive Samples	Negative Samples

View equation

How many Bronchoalveolar Lavage (BAL) samples do you need?

Total Samples	Positive Samples	Negative Samples

View equation

How many Anterior Nasal samples do you need?

Total Samples	Positive Samples	Negative Samples

View equation

Plasma

How many Ebola Plasma samples do you need?

Total Number	Positive Samples	Negative Samples

View equation

NP Residuals

Anterior Nasal

How many Anterior Nasal samples do you need?

Total Number	Positive Samples	Negative Samples

View equation

How many NP Residual Flu samples do you need?

Total Number	Positive Samples	Negative Samples

View equation

Expand

Cervical/ Vaginal

How to add new sample types

1,

If you haven't already, go to 'data exports, reports, and stats'
- click the 'all data' reports button 'export data'
- click 'csv/microsoft excel (raw data), and press export data (this saves a copy of the datatbase in case anything goes wrong)
Add a sample type in the infectious_disease_sample dropdown or its subsidiaries such as sample_type, or ebola_plasma_samples as needed

2,

Then copy:
- bal_residual_numbers_4
- requested_number_hpv_cervical (and all 4 other grey highlighted fields.
Drag them to thier separate area (below the correct sample type)
- give the a unique color
- give them appropriate variable names
- make sure the branching and calculated values work

See 3 lower on this page!!!!!

How many Cervical/Vaginal samples do you need?

Total Number	Positive Samples	Negative Samples

View equation

Upload file

3,

To add the positive and negative sample requests in the budget, Copy:
- proposed_budget_14
- proposed_budget_15
Drag the coppied version below originals
Change the name from 'HPV Cervical/vaginal' to your new sample type
Make sure the branching works with the new sample type so it can show in the budget
Correct the piping fields to reflec the new sample type

go to 4 to complete!!

BIOREPOSITORY SERVICES

Services

Quantity

Unit Cost

Total

Positive

NP Residuals COVID-19

______

$______.00

Negative

NP Residuals COVID-19

______

$______.00

Positive

Bronchoalveolar Lavage (BAL)

______

$______.00

Negative

Bronchoalveolar Lavage (BAL)

______

$______.00

Positive

Anterior Nasal COVID-19

______

$______.00

Negative

Anterior Nasal COVID-19

______

$______.00

Positive

Ebola Plasma

______

$______.00

Negative

Ebola Plasma

______

$______.00

Positive

NP Residual Flu

______

$______.00

Negative

NP Residual Flu

______

$______.00

Positive

Anterior Nasal Flu

______

$______.00

Negative

Anterior Nasal Flu

______

$______.00

Positive

HPV Cervical/Vaginal

______

$______.00

Negative

HPV Cervical/Vaginal

______

$______.00

Total Budget

$______.00

*Costs are inclusive of Emory F&A Rate @ 56.5%

* Your bill was calculated based on your stated primary funding source: ______

BIOREPOSITORY SERVICES

Description of Services	Quantity	Unit Cost	Total
Positive	______	$______.00	$______.00
Negative	______	$______.00	$______.00


Total Budget			$______.00

*Costs are inclusive of Emory F&A Rate @ 56.5%

* You bill was calculated based upon your stated primary funding source: ______

*IMPORTANT: You have chosen 'Ebola Plasma Samples',

As we do not have pre-defined prices for these items, this cost will be added to your quote later.

4,

You need to update the nested sum tables to add the new sample to the budget. Update:
- total_budget
- requested_number
- positive_samples
- negative_samples

View equation

Number of requested samples
How many samples are positive?
How many samples are negative?

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.

GCRC Biorepository Request Form

How to add new sample types

1,

2,

Proposed Budget

3,

4,

You have selected an option that triggers this survey to end right now.