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ADHD Research Study

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ADHD RESEARCH STUDY AGREEMENT

This Agreement is entered into as of the Effective Date below by and between:

Sponsor Name:

Research Site / Principal Investigator:

Effective Date:

RECITALS

WHEREAS, Sponsor is engaged in the development and sponsorship of clinical and/or observational research concerning attention-deficit/hyperactivity disorder (ADHD) and seeks to retain the Research Site to perform study activities in accordance with the protocol and applicable law; and

WHEREAS, Research Site, through its Principal Investigator, possesses the facilities, personnel, and regulatory approvals necessary to conduct the ADHD research study described in this Agreement under the terms set forth below; and

WHEREAS, the parties desire to set forth their respective duties, payment terms, confidentiality obligations, and other provisions governing the conduct of the Study.

SCOPE OF WORK

Research Site shall perform the research activities described in the Study Protocol and any approved amendments. Work shall include participant recruitment, screening, informed consent, study visits, data collection, safety monitoring, reporting of adverse events, and study close-out activities. The Study Protocol number or title:

PAYMENT TERMS

Total Compensation: $ payable pursuant to the following schedule.

Invoicing: Research Site shall submit invoices to Sponsor in accordance with the schedule above. Payment is due within days of Sponsor's receipt of a proper invoice. Late payment shall accrue interest at % per month or the maximum permitted by law, whichever is less.

TERM AND TERMINATION

Term: This Agreement shall commence on the Effective Date and continue until unless earlier terminated in accordance with this Section.

Termination for Convenience: Either party may terminate this Agreement without cause upon days' prior written notice to the other party. Sponsor shall pay Research Site for work performed and documented expenses incurred through the effective date of termination in accordance with the Payment Terms.

Termination for Cause: Either party may terminate immediately upon written notice if the other party materially breaches this Agreement and fails to cure such breach within 30 days after receipt of written notice specifying the breach. Material breach includes but is not limited to failure to comply with applicable human subjects protection requirements, fraud, or repeated failure to perform obligations hereunder.

CONFIDENTIALITY

Definition: "Confidential Information" means non-public information disclosed by one party to the other related to the Study, proprietary methodologies, study data, analyses, and sponsor business information, whether disclosed orally, visually, or in writing and marked or identified as confidential.

Obligations: Receiving party shall (a) hold Confidential Information in strict confidence, (b) use it solely for performance of obligations under this Agreement, and (c) restrict disclosure to personnel with a need to know who are bound by confidentiality obligations no less protective than this Agreement. Confidential Information shall not include information that is or becomes generally available to the public other than by breach of this Agreement, is already rightfully known to the receiving party, or is lawfully obtained from a third party without restriction.

Duration: Confidential information shall be maintained in confidence for years following the end of the Study, except that trade secrets shall be protected for as long as they qualify as trade secrets.

DATA, PUBLICATION, AND INTELLECTUAL PROPERTY

Data Ownership: Sponsor shall own all Study data and results arising from Sponsor-funded activities, subject to any de-identified datasets or copies reasonably provided to Research Site for academic use as agreed in writing. Research Site shall maintain accurate source records and make them available for audit as required by Sponsor and applicable law.

Publication: Research Site may publish aggregated, de-identified results with Sponsor's prior written review to protect confidential information and patentable inventions. Sponsor shall not unreasonably withhold consent, but may request reasonable redactions to protect Confidential Information or patent filings.

COMPLIANCE, REGULATORY MATTERS, AND INSURANCE

Regulatory Compliance: Research Site shall conduct the Study in accordance with the approved Study Protocol, applicable laws and regulations governing human subjects research, and all applicable institutional review board (IRB) or ethics committee requirements. Research Site shall promptly notify Sponsor of any reportable safety events or regulatory actions.

Insurance and Indemnity: Each party shall maintain insurance customary for the conduct of research. Research Site shall indemnify, defend and hold harmless Sponsor from claims arising out of Research Site's gross negligence or willful misconduct. Sponsor shall indemnify Research Site for claims arising from Sponsor's study design or proprietary materials provided by Sponsor, except to the extent caused by Research Site's negligence.

REPORTING, AUDIT, AND RECORDS

Reports: Research Site shall provide Sponsor with timely study progress reports, safety reports, and final study reports in the format and frequency set forth in the Scope of Work.

Audit Rights: Sponsor and its designees shall have the right to audit records and facilities relevant to the Study upon reasonable prior notice and during normal business hours to verify compliance with this Agreement and applicable laws.

GOVERNING LAW & ENTIRE AGREEMENT

Governing Law: This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to conflict of laws principles.

Entire Agreement: This Agreement, together with the Study Protocol and any attachments or executed amendments, constitutes the entire agreement between the parties with respect to the Study and supersedes all prior understandings, negotiations and agreements, whether written or oral.

MISCELLANEOUS

Notices: All notices required or permitted hereunder shall be in writing and delivered to the contact persons listed below. Sponsor contact: , Address: .

Research Site contact: , Address: .

Human Subjects Approval Obtained: Yes

Enrollment Target:

Sponsor (Print Name):

By:

Date:

Research Site / PI (Print Name):

By:

Date:

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What the ADHD Research Study document is and why it matters

The ADHD Research Study document is the core enrollment packet for prospective participants: it combines the study protocol summary, informed consent language, eligibility screening, contact details, procedures schedule, and data-use permissions. For U.S.-based research this document supports IRB review, documents consent (including assent for minors), and records data collection permissions required for compliant clinical and behavioral research.

The document’s primary purpose and practical benefits

A clear ADHD Research Study form ensures legally valid informed consent, consistent eligibility screening, and auditable records for IRB oversight and regulatory compliance. Accurate documentation reduces participant risk, streamlines data collection, and preserves the integrity of study results while enabling secure, reproducible recordkeeping.

The document’s primary purpose and practical benefits

Who prepares, completes, and reviews the ADHD Research Study materials

Each role must keep documented evidence of consent and any subsequent amendments for audit and participant follow-up.

  • Principal investigators and study coordinators who draft protocol elements and collect participant information in a standardized format.
  • Institutional Review Board (IRB) staff and compliance officers who review consent wording, risk descriptions, and data-protection measures.
  • Participants and, when applicable, legal guardians or parents who read, initial, and sign consent and assent forms to permit study participation.

Essential components included in a professional ADHD Research Study packet

A complete packet organizes the study into clear sections so reviewers and participants can find required information quickly.

Protocol summary

Briefly describe objectives, hypothesis, study design, duration, and participant time commitments so reviewers and participants understand scope and expectations.

Inclusion/exclusion

List objective eligibility criteria, medical and medication exclusions, and screening procedures used to confirm participant suitability for safety and validity.

Informed consent

Plain-language risks/benefits, alternatives, voluntary participation statement, withdrawal procedures, and signature block for participant and witness or guardian if required.

Study procedures

Detailed schedule of visits, assessments, questionnaires, medication or device usage, and estimated time per visit to set clear expectations.

Data privacy

Describe data collection, storage, de-identification, HIPAA protections, and who will access identifiable information during and after the study.

Contacts & emergencies

Provide principal investigator and 24/7 contact information for study-related questions and instructions for reporting adverse events or medical issues.

Required security and compliance information to include

Encryption: AES-256 at rest
Transport security: TLS 1.2/1.3 in transit
HIPAA: BAA required for PHI
Audit trail: Timestamps and IP logs
Access control: Role-based permissions
Certifications: SOC 2 Type II, ISO 27001

Consequences and legal risks of incorrect or missing documentation

IRB noncompliance: Study suspension risk
HIPAA breach: Civil and criminal penalties
Invalid consent: Data exclusion from analysis
Participant harm: Liability and reporting obligations
Regulatory fines: Federal or state penalties
Reputational damage: Trust and funding loss

Common mistakes to avoid when preparing the study packet

  • Omitting clear assent language for minors or failing to obtain parental permission when participants are under the age of majority.
  • Using ambiguous consent wording, especially around risks, data sharing, or withdrawal rights, which can render consent invalid or unclear.
  • Failing to document versions and dates of consent forms and protocol amendments, creating audit gaps during IRB or sponsor review.
  • Collecting signatures on unsigned or scanned drafts rather than the final IRB-approved version, which can invalidate enrollment.

Step-by-step workflow to complete the ADHD Research Study form

Follow this sequence to prepare, obtain, and file consent and enrollment documentation accurately and in compliance with IRB and regulatory expectations.

  • 01
    Prepare documents: Assemble protocol, consent, questionnaires, and version control before enrollment.
  • 02
    Verify eligibility: Confirm inclusion/exclusion criteria using objective screening tools.
  • 03
    Obtain consent: Review consent with participant; document signature and date.
  • 04
    Archive records: Store signed forms and audit logs according to retention rules.

Configuring the online eConsent workflow for the study

Design the digital workflow to capture consent, authenticate signers, record audit trails, and route completed forms to study systems.

Field | Configuration Setting
Authentication method Email link, SMS code, or stronger MFA
Field types Signature, initials, checkboxes, conditional fields
Routing logic Sequential or parallel signer order
Retention settings Audit trail retention period configured

Where to send completed ADHD Research Study documents

Completed forms must be routed to the IRB, institutional records, and the participant; maintain copies in secure systems and the study sponsor's archive.

  • To IRB: Upload final signed forms to the IRB portal per submission instructions.
  • To Sponsor: Send redacted or identified copies per sponsor data agreements.
  • To EMR: If authorized, add study enrollment note to the participant’s electronic medical record.
  • To Participant: Provide a final signed copy and study contact information for questions.

Technical considerations for eSigning and eConsent platforms

Ensure chosen tools support HIPAA BAAs when PHI is present and maintain exportable audit records.

  • Integrations: Salesforce, NetSuite, Google Workspace
  • File formats: PDF, DOCX, HTML, Excel
  • Authentication options: Email link, SMS code, KBA, SSO

Key timelines and deadlines to track for study documentation

Track IRB submission, enrollment windows, adverse event reporting windows, and retention obligations to maintain compliance and data integrity.

IRB submission deadline:

Submit consent and protocol by institution-set cutoff to secure approval before enrollment.

Enrollment period:

Open and close dates determine when participants are eligible to enroll.

Adverse event reporting:

Report serious events per IRB/sponsor timeframe, often within 24–72 hours.

Consent effective date:

The date the participant signs is the consent effective date for participation.

Annual continuing review:

Prepare materials for continuing IRB review as required by the IRB schedule.

Project milestones from protocol to archival

A sequential milestone view helps teams monitor approvals, enrollment, and closeout activities with clear handoffs between stages.

01

Protocol finalization

Finalize study documents and version control before IRB submission.

02

IRB approval

Receive written approval and approved consent versions from the IRB.

03

Participant enrollment

Begin screening and documenting signed consent for enrolled participants.

04

Closeout & archive

Complete final reports and securely archive study records.

Practical examples of eConsent and documentation workflows

Two anonymized scenarios illustrate typical operational approaches used in ADHD studies across institutions.

University clinical study

A university team implemented electronic informed consent for remote participants to increase reach and maintain audit trails

  • Enrollment increased among remote volunteers by streamlining screening and signature capture
  • Signed copies, version history, and audit logs were archived to the IRB system, simplifying continuing review submissions and monitoring.

Community clinic trial

A community clinic used remote notarization for guardian signatures when in-person visits were not possible

  • KBA and video confirmation supported signer identity
  • Final signed records were exported to secure storage and provided to participants via encrypted PDF for their records.

Comparing eSignature vendors for supporting ADHD Research Study workflows

Basic pricing and capability comparisons oriented toward research workflows; signNow is listed first for ease of comparison.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day trial Varies Varies Varies Varies
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies

Frequently asked questions about completing and eSigning the ADHD Research Study

Answers to common operational, legal, and technical questions encountered when using electronic consent and eSignature for research.


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