Can this form be signed electronically?

Yes. Electronic signatures are legally valid under the ESIGN Act (15 U.S.C. ch. 96) and UETA in most states, provided intent, consent, attribution, and record retention requirements are met.

Do I need an IRB approval attached?

Attach the IRB approval letter or documentation when available; a pending status must be clearly indicated. Many IRBs will return submissions missing approvals for completion.

What if patient identifiers are required?

Prefer coded identifiers when possible; if PHI is included, ensure HIPAA safeguards and a business associate agreement are in place before sharing with third parties.

Who can sign on behalf of a site?

Authorized signatory must be a delegated individual listed in the delegation log; investigator signatures confirm responsibilities and oversight for the site's conduct.

How long should I keep the completed form?

Follow sponsor and regulatory retention schedules: at minimum keep for the active study term plus applicable federal years, and six years for HIPAA-covered records.

What causes most IRB returns?

Common causes include missing consent versions, incomplete investigator delegations, unclear adverse event escalation paths, and inconsistent protocol identifiers across attachments.

Electronic Signature
Templates
Healthcare
Healthcare Clinical Investigations Form

Healthcare Clinical Investigations Form

This template is fully customizable. Edit the text, fill out the fields, and send it for signature. Give it a try!

Healthcare Clinical Investigations Form

Study Title: Protocol Number:

Sponsor: Principal Investigator:

Investigational Site: Enrollment Date:

Patient Information

Patient Full Legal Name Date of Birth Gender (check one)

Male Female Other:

Address Primary Phone Email

Emergency Contact

Name Relationship Phone

Insurance Information

Insurance Provider Policy Number Group Number Subscriber Name (if different)

Medical History

Current Medications Known Allergies

No known allergies Allergies present (specify below)

Prior Surgeries / Hospitalizations Chronic Conditions / Diagnoses

I am pregnant or suspect I may be pregnant I am breastfeeding

Study Procedures & Risks

Description of Procedures

Expected Duration of Participation: Number of Study Visits:

Biological Samples

Blood samples Tissue samples Other (specify below)

I understand that participation involves potential risks and benefits. The principal investigator has explained the reasonably foreseeable risks, discomforts, and potential benefits associated with participation in this clinical investigation, including the possibility of no direct benefit. I have had the opportunity to ask questions and they were answered to my satisfaction.

Confidentiality, Data Use, and HIPAA Authorization

Records generated from this investigation, including medical records and laboratory results, may be used for the purposes of the study and may be reviewed by authorized representatives of the sponsor, institutional review board, and regulatory authorities. Identifiable information will be handled in accordance with applicable privacy protections. By signing below I authorize the release of my relevant medical records to study personnel for the purposes of this investigation.

I authorize storage of collected biological specimens for future research related to the objectives of this study: Yes No

If yes, specify storage duration or conditions Authorization Expiration Date

Voluntary Participation & Withdrawal

Participation in this clinical investigation is voluntary. I may withdraw from the study at any time without penalty or loss of benefits to which I am otherwise entitled. If I withdraw, the investigator may retain and use data and samples collected prior to withdrawal as required for the integrity of the study unless I specifically request destruction of identifiable materials in writing.

Compensation & Costs

Any compensation for participation, payments for travel, and cost liabilities (including treatment of study-related injury) have been explained. I understand the financial responsibilities and any compensation arrangements as described:

Acknowledgment & Consent

By signing below I certify that I have read and understand the information provided in this form, that the investigator has explained the purpose, procedures, risks, and possible benefits of the clinical investigation, and that my questions have been answered. I consent to participate in the clinical investigation described above and authorize the use and disclosure of my health information as set forth in this form.

I acknowledge that I have received a copy of this signed consent and that I may contact the principal investigator for any questions about the study, my rights as a participant, or study-related injuries.

Patient Printed Name:

Relationship to Patient (if signer is legal guardian):

Signature:

Date:

Certification: I attest under penalty of perjury and under applicable local law that the information provided on this form is true and accurate to the best of my knowledge and that I am authorized to sign on behalf of the individual named above if signing as guardian.

What the Healthcare Clinical Investigations Form Is

The Healthcare Clinical Investigations Form is a standardized document used to collect protocol details, investigator information, patient eligibility criteria, consent confirmations, and safety monitoring plans for clinical research activities. It supports institutional review board (IRB) review, regulatory submissions, and study records by consolidating study identifiers, investigational product data, and reporting obligations into a single record that can travel with the study file and be referenced throughout the trial lifecycle. Accurate completion helps confirm compliance with applicable human-subject protections and data security requirements.

Why this form matters for compliance and study management

A complete Healthcare Clinical Investigations Form documents researcher responsibilities, participant protections, and safety reporting pathways, reducing regulatory risk and improving oversight during a trial. It centralizes key study metadata needed by IRBs, sponsors, and monitors and helps demonstrate adherence to applicable federal and state requirements.

Typical users and signatories for this form

The Healthcare Clinical Investigations Form is completed and reviewed by multiple parties involved in clinical research.

Principal investigators and delegated research staff who enter protocol details, eligibility criteria, and safety monitoring plans for IRB review and sponsor oversight.
Institutional review boards (IRBs) and ethics committees that verify subject protections and approve study start or amendments.
Study sponsors, contract research organizations (CROs), and monitors who require this form for regulatory submissions, audits, and trial management.

Clear role separation and accurate signatory identification reduce processing delays and evidence gaps during audits and safety reviews.

Step-by-step: completing the Healthcare Clinical Investigations Form

Follow these sequential steps to prepare a submission-ready form and reduce back-and-forth with reviewers.

01

Gather Documents: Collect protocol, consent, CVs, and sponsor delegations.
02

Complete Fields: Enter required metadata and confirm effective dates.
03

Attach Approvals: Upload IRB approvals and supporting documents.
04

Sign and Route: Obtain required signatures and send to IRB or sponsor.

Recommended digital workflow settings for e-submission

Configure these workflow settings to support secure eSubmission, audit trails, and conditional data capture.

Field	Configuration
Authentication	Email link with optional SMS code for signer verification
Conditional Fields	Show safety details only when adverse events reported
Audit Trail	Enable time‑stamp, IP, and action logging for each signature
Storage	Encrypt at rest with access controls and versioning

Typical eSubmission flow for a clinical investigations form

An electronic workflow streamlines review, supports secure storage, and preserves a compliance-ready audit trail.

Upload Document: Sender uploads completed PDF or DOCX to the platform
Place Fields: Sender positions signature, date, and required fields
Signer Authentication: Signers authenticate via email link or stronger methods
Store Record: Signed copy and audit trail saved for retention

Technical and integration considerations for eSubmission

Choose a platform that supports secure file formats, audit trails, and the integrations required by your organization.

File Formats: PDF and DOCX support preserves formatting and metadata
Integrations: Connectors for Google Workspace, Microsoft 365, and NetSuite
Authentication: Options for SMS codes, KBA, or enterprise SSO

Confirm the platform supports HIPAA-compliant workflows, audit trails, and retention policies that meet institutional and regulatory needs.

Essential privacy and security fields to include

Patient Identifier: Use coded ID, not full PHI

Consent Status: Yes, No, Withdrawn

Data Access Level: Role-based access only

Retention Flag: Indicates archival duration

Audit Trail: Timestamps and signer attribution

Security Controls: Encryption and MFA enabled

Primary legal and regulatory risks of incomplete forms

HIPAA Violations: Civil fines (45 CFR §160)

FDA Noncompliance: 21 CFR reporting sanctions

IRB Delays: Study start postponement

Data Integrity: Query findings, audit impact

Criminal Risk: Intentional falsification charges

Contract Breach: Sponsor remedies and costs

Common mistakes that delay review or create compliance gaps

Using inconsistent protocol identifiers across documents that cause misrouting and duplicate review requirements.
Entering incomplete safety contact details that prevent timely adverse event escalation to sponsor or IRB.
Attaching unsigned consent forms or missing investigator delegation logs that trigger IRB return for corrections.
Failing to record version history or effective dates, producing uncertainty about which procedures were in force.

Core components of a professional Healthcare Clinical Investigations Form

A complete form combines administrative, clinical, and safety elements so reviewers can assess study conduct, participant protections, and reporting pathways.

Protocol Summary

Concise study objectives, design, endpoints, and inclusion/exclusion criteria to allow rapid reviewer assessment of scientific validity.

Informed Consent Reference

Links to the exact consent version, key consent elements, and consent status to verify participant authorization and documentation.

Investigator Details

Principal investigator credentials, delegated staff list, and contact points to confirm oversight and delegation of study tasks.

Safety Reporting

Defined adverse event escalation, sponsor contacts, and expected timelines for expedited reporting and periodic safety updates.

Data Management

Recordkeeping plan, data transfer agreements, and deidentification or coding approach for participant data handling.

Regulatory Attachments

IRB approval letters, sponsor agreements, and other supporting documentation required for compliance and audit readiness.

Supporting documents and export options to include

Attach or export key supporting files in interoperable formats to preserve evidentiary value and ensure compatibility with review systems.

Protocol

Include the full protocol in PDF/A format so reviewers and auditors see the authoritative study plan and version history preserved.

Consent Form

Attach signed, dated informed consent PDFs linked to participant IDs to demonstrate consent for each enrolled subject.

CVs and Delegation

Upload investigator CVs and delegation logs in PDF or DOCX to verify qualifications and assigned responsibilities.

Safety Reports

Export adverse event narratives and SAE reports as PDFs with embedded audit trails for regulator submission and sponsor review.

Typical timelines and processing expectations

Timelines vary by IRB and sponsor; plan for initial review, required registrations, and ongoing reporting obligations.

IRB Initial Review:

Commonly 30–60 days for full-board review depending on IRB workload

ClinicalTrials.gov Registration:

Register certain interventional trials no later than 21 days after first participant enrollment

Annual Continuing Review:

Submit continuing review materials at least annually unless exempted

Serious Adverse Event Reporting:

Follow sponsor and FDA timelines; expedited reporting may be 7–15 days

Study Closeout:

Archive final reports and documentation per sponsor and IRB closure requirements

Sample eSignature pricing and capability snapshot for clinical workflows

Compare starting price, trial availability, bulk send, audit trail, HIPAA support, and envelope caps when evaluating eSignature vendors for clinical investigations.

	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 free trial, no credit card required	Varies by plan	Varies by plan	Varies by plan	Varies by plan
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No

Frequently asked questions about completing and submitting the form

Answers to common questions about signatures, required attachments, electronic submission, and recordkeeping for clinical investigations.

Need help? Contact support

Can this form be signed electronically?
Yes. Electronic signatures are legally valid under the ESIGN Act (15 U.S.C. ch. 96) and UETA in most states, provided intent, consent, attribution, and record retention requirements are met.
Do I need an IRB approval attached?
Attach the IRB approval letter or documentation when available; a pending status must be clearly indicated. Many IRBs will return submissions missing approvals for completion.
What if patient identifiers are required?
Prefer coded identifiers when possible; if PHI is included, ensure HIPAA safeguards and a business associate agreement are in place before sharing with third parties.
Who can sign on behalf of a site?
Authorized signatory must be a delegated individual listed in the delegation log; investigator signatures confirm responsibilities and oversight for the site's conduct.
How long should I keep the completed form?
Follow sponsor and regulatory retention schedules: at minimum keep for the active study term plus applicable federal years, and six years for HIPAA-covered records.
What causes most IRB returns?
Common causes include missing consent versions, incomplete investigator delegations, unclear adverse event escalation paths, and inconsistent protocol identifiers across attachments.

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