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PAG8MQSiqcax4RVFmjRUpTDinweKiPMZHIIVPRvHe

Partners HealthCare ELN Exceptions Request Form

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Research ELN Exemption/Variance requests will be granted if the review process determines that the laboratory, research group or department:

Cannot use LabArchives due to legitimate technical or documented business constraints; or
Has sufficiently demonstrated maintenance of data integrity by implementing systems or processes that meet the Research Data Electronic Systems/ELN Minimum Standards.

Approval of Exemption/Variance requests is limited to the ELN Oversight Committee or designee(s).

Exemption to the policy will be granted to PIs with well-established electronic lab or data management systems and processes that meet the criteria set forth in the ELN policy. Generally, exemptions will approved for the duration of the laboratory, research group or department's active projects. Exemptions will be reviewed periodically by the ELN Support Team, e.g., on an annual basis or during award renewal cycles to ensure the systems or processes continue to meet policy standards.
Variance requests will be granted for a maximum of one year. The PI of an approved Variance is responsible for complying with all approval requirements, including resubmission prior to variance expiration if an extension is required. Systems or processes approved under a variance may not be modified without prior approval by the ELN Oversight Committee.

ELN Policy (available internally on Archer)

The option "" can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?

Are you requesting an Exemption or a Variance

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Exemption

Variance

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Is this request for an exception for clinical research projects that are 21 CFR Part 11 compliant?

This Policy does not apply to
- Clinical research projects that utilize electronic lab or data management systems, processes, and ELNs that are 21 CFR Part 11 compliant
- Sponsor-initiated clinical trials that utilize sponsor systems and processes.

* must provide value

Yes

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Institution

Department Name

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PI Name

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Primary Contact Name

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Primary Contact Email

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Primary Contact Phone Number

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Please provide a brief description of your laboratory/work environment and work/process flow

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What tools/systems are you using for data management and record keeping?

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Do your tools/systems have a completed Partners InfoSec Risk Assessment?

The ELN must be compliant with all Partners Enterprise Information Security Policies, Standards, and Procedures.

If No, depending on your tool/system, you may be required to request a risk assessment. The ELN Support team will work with you to determine if needed. For more info: https://rc.partners.org/risk

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Yes

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If no is a Risk Assessment required by RISO?

Yes

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Please enter Risk Assessment reference number, enter a comment, or upload attachment below.

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Risk Assessment Attachment

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The ELN must be compliant with applicable regulatory and legal requirements. Please check the requirements that apply to your data.

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Health Insurance Portability and Accountability Act (HIPAA)

Mass General Law, Chapter 93H (M.G.L.c.93H)

EU General Data Protection Requirement (GDPR)

None of the above

The ELN must include Data Integrity Controls for the entire Data Life Cycle. Check if your systems have:

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Date time, user, and action logs of any modification to Research Data

Inability to delete data or record keeping activities without appropriate deletion logs

Control of ELN access and user management by PI and/or Lab Manager or designee

Documentation of Research Data chain of custody (i.e. Ownership, PI Transfer In/Out)

Logs that record access to information or data sharing activities

None of the above

Please provide a brief justification for the exception request

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The ELN Support Team will review this request and then set up a meeting with you to collect additional information to ensure your system(s) meet the minimum standards outlined above.

All requests for exceptions will be forwarded to the ELN Oversight Committee (consisting of Partners Chief Academic Officer, BWH SVP for Research, MGH SVP for Research, McLean Chief Scientific Officer, and Partners Chief Research Information Officer.)

**Please note review process timelines have not been established and will be published at a later date.

Please provide any additional information in support of the request:

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