Data Management Plan Template Nih

Standard Operating Procedure: NIH Data Management and Sharing (DMS) Plan Architecture

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1. Executive Summary & Purpose

This Standard Operating Procedure (SOP) defines the institutional-grade engineering lifecycle for drafting, validating, and maintaining Data Management and Sharing (DMS) Plans compliant with the National Institutes of Health (NIH) NOT-OD-21-013 mandate.

The purpose of this procedure is to establish a repeatable, auditable protocol for Principal Investigators (PIs) and Data Stewards to operationalize FAIR (Findable, Accessible, Interoperable, Reusable) data principles. Adherence to this SOP ensures institutional compliance, protects intellectual property, mitigates regulatory audit risks, and standardizes data disposition workflows prior to grant submission.

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2. Scope & Prerequisites

2.1 Scope

This SOP applies to all research personnel, PIs, Co-Investigators, and Data Management staff at Template Registry who are preparing grant applications, contract proposals, or progress reports involving NIH funding where data generation is anticipated.

2.2 Prerequisites & Tooling

• Software/Environment Access:
  • Institutional instance of DMPTool (dmptool.org) via institutional SSO.
  • REDCap / Electronic Data Capture (EDC) production environment.
  • Institutional Secure Research Data Storage (SRDS) tier-1 cluster access.
• Documentation & Standards:
  • Active NIH grant solicitation (FOA / RFA).
  • Controlled Access Repository Identification Matrix.
  • Institutional Data Classification Taxonomy (Level 1–4).

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3. Roles & Responsibilities

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4. Step-by-Step Procedure

Phase 1: Pre-Submission Assessment & Scoping

• 1.1 Review the specific NIH Institute, Center, or Office (ICO) data sharing policies tied to the target Funding Opportunity Announcement (FOA).
• 1.2 Inventory anticipated data types (e.g., genomic, phenotypic, imaging, survey, software code) and classify them using the Institutional Data Classification Taxonomy.
• 1.3 Estimate total data volume metrics (e.g., GB/TB per annum) and lifecycle retention windows.

Phase 2: Element-by-Element Plan Drafting (DMPTool Integration)

• 2.1 Initialize a new plan in DMPTool using the "NIH-Default (FOR 2023+)" template.
• 2.2 Element 1: Data Type: Document the source, format (e.g., .fastq, .csv, DICOM), and approximate volume of data generated, noting whether data are digital or physical.
• 2.3 Element 2: Related Tools, Software and/or Code: Specify specialized software, code repositories (e.g., GitHub), or analysis pipelines required to access or manipulate the data. Include version-control protocols.
• 2.4 Element 3: Standards: Define metadata standards, ontologies (e.g., CDISC, fastq, DataCite), and file-naming conventions to ensure interoperability.
• 2.5 Element 4: Data Preservation, Access, and Associated Timelines: Identify repositories (e.g., dbGaP, Dryad, GEO, institutional repository) and establish timeline commitments (sharing no later than publication or close of grant, whichever comes first).
• 2.6 Element 5: Access, Distribution, or Reuse Considerations: Detail IRB approvals, informed consent language, de-identification protocols (HIPAA Expert Determination or Safe Harbor), and restrictions for controlled-access datasets.
• 2.7 Element 6: Oversight of Data Management: Assign operational oversight responsibility, specifying roles, monitoring intervals, and compliance checkpoints.

Phase 3: Technical Validation & Cost Allocation

• 3.1 Validate repository compatibility against NIH repository selection criteria (persistent identifiers, metadata availability, security controls).
• 3.2 Calculate allowable, justifiable costs for data management and sharing (e.g., repository fees, specialist staff, curation tools) and align them with the grant budget justification.
• 3.3 Submit draft to the Lead Data Architect for structural and technical metadata validation.

Phase 4: Institutional Review & Finalization

• 4.1 Route the finalized DMPTool export through the Institutional Compliance Officer for privacy and IRB alignment.
• 4.2 Attach the finalized PDF plan to the internal Grants & Contracts Office (GCO) portal at least 5 business days prior to the sponsor deadline.
• 4.3 Archive the approved version-controlled document within the Template Registry institutional DMS repository (/registry/dms/archives/).

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5. Quality Assurance & Pro-Tips

Best Practices (Pro-Tips)

• Consent Language: Ensure clinical informed consent protocols explicitly contemplate broad secondary research use to prevent repository rejection post-award.
• Persistent Identifiers (PIDs): Always use DOIs or RRRIDs for published datasets to satisfy tracking metrics during Research Performance Progress Report (RPPR) cycles.
• Budget Realism: Never leave the NIH DMS budget section blank; even if utilizing free institutional repositories, detail personnel time spent on curation.

Common Pitfalls

• Pitfall: Vague repository naming (e.g., "Institutional Server"). Correction: Name specific, recognized trusted repositories (e.g., "National Institute of Mental Health Data Archive (NDA)").
• Pitfall: Failing to update plans upon protocol modifications. Correction: Trigger a plan amendment review during annual RPPR submissions.

Quantitative Thresholds

• Review SLA: Institutional compliance turnaround within $\le 48$ hours.
• Storage Redundancy: Tier-1 SRDS must maintain $\ge 3$ geographic replicas for active research data.

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6. Frequently Asked Questions (FAQ)

Q1: What happens if our chosen repository changes during the grant lifecycle? A1: Minor repository shifts require an administrative update documented in the annual RPPR. Major shifts affecting data access tiers or controlled access require prior approval from the NIH Program Officer and an amended DMS plan filed through the GCO.

Q2: Are administrative data and lab notebooks subject to the NIH DMS policy? A2: No. The policy applies strictly to scientific data—defined as data underlying findings in peer-reviewed publications arising from NIH-funded research. Raw lab notes, preliminary drafts, and peer-review correspondence are exempt.

Q3: How are costs for cloud storage justified within the application? A3: Costs must be specific, justified, and confined to the period of performance. Permanent, long-term archival costs occurring after the grant period are generally unallowable unless utilizing repository-specific tiered pricing models approved by the NIH ICO.