ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals. 

The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). ClinicalTrials.gov has a public site, open to the public to search and view clinical trials, and a restricted access user platform, Protocol Registration and Results System (PRS) where researchers upload and maintain their clinical trial record(s). The information uploaded to the PRS site is reviewed and released by the PRS staff at NLM to the public site. 

Public Site:  https://clinicaltrials.gov/ 

PRS Site:  https://register.clinicaltrials.gov 

For more information on ClinicalTrials.gov, visit About ClinicalTrials.gov. 

The NIH defines a clinical trial as ‘A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.’ Any research study that answers ‘yes’ to the all the four questions below is considered a clinical trial: 

• Does the study involve human participants? 

• Are the participants prospectively assigned to an intervention? 

• Is the study designed to evaluate the effect of the intervention on the participants? 

• Is the effect being evaluated a health-related biomedical or behavioral outcome? 

Researchers can also utilize the NIH Clinical Trial Decision Tool to determine whether their research is considered a clinical trial. 

National Institutes of Health (NIH) funded clinical trials 

Clinical trials funded by NIH, in part or in whole, require registration and result reporting per NIH policy. If the answer to all the four questions in question #2 above is ‘yes’, then the research study meets the NIH definition of a clinical trial and must be registered.  

FDA defined Applicable Clinical Trials (ACT) 

Applicable clinical trials, as defined by the Final Rule (42 CFR 11) require registration and result reporting, regardless of funding source. ACTs are: 

• Controlled clinical trials of FDA regulated drugs & biologics (Phase II to IV) 

• Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies)  

Researchers can also utilize the NIH ACT Checklist to determine whether research is considered an applicable clinical trial. 

International Committee of Medical Journal Editor (ICMJE)

ICMJE’s clinical trial registration policy requires registration of clinical trials in a public registry as a condition of consideration for publication. This includes: 

• Research that meets the NIH definition of a clinical trial 

• Applicable Clinical Trials (ACTs), including phase I drug studies and device feasibility studies 

Center for Medicare and Medicaid Services (CMS) 

CMS requires a National Clinical Trial (NCT) number for coverage of routine costs of qualifying clinical trials (including phase I drug studies and device feasibility studies). 

Requirement	Protocol Registration	Results submission
NIH funded (partly or in whole)	Yes	Yes
Federal agencies/department funded	Yes	Yes
FDA ACTs	Yes	Yes
CMS	Yes	Yes
ICMJE	Yes	No
Non-profit and other funding organizations	Based on award specific terms and conditions

Who is a Responsible Party? 

A Responsible Party is the sponsor of a clinical trial, grantee or awardee for clinical trials that are federally funded or internally (UTD) funded. It can also be the principal investigator (PI) of the clinical trial if so, designated by the sponsor, grantee or awardee, that is responsible for conducting the trial, has access to and control over the data from clinical trial, has the right to publish the results of the trial, and has the ability to meet all the requirements for the submission of clinical trial information. 

Only tenure/tenure-track faculty and clinical professors are eligible to assume the role of Responsible Party at UTD. 

Refer to the ClinicalTrials.gov PRS SOP for responsibilities and definition of a Responsible party. 

Please note that The University of Texas at Dallas should not be selected as the Responsible Party. Record(s) that make this selection will be updated to their respective PI (or FS) listed in the record. 

A user account is required to access, create and maintain records on ClinicalTrials.gov PRS. Requests for a new user account shall be sent to the Clinical Trials Office (CTO) via email. Please provide CTO with the following information: 

• Subject line – Request for a new ClinicalTrials.gov PRS user account 
• User’s full name 
• User’s UTD email address 
• IRB number for the clinical trial 
• IRB Protocol title 

User account requests from research staff shall copy the Principal Investigator on the email requests. 

ClinicalTrials.gov will email account information and a temporary password to the email address you provided to create an account. Activate your account with the temporary password provided in the email. 

NLM has resources such as ‘Using PRS’ to help users with record creation and maintenance whereas ‘Record Review’ is intended to help users understand the PRS quality control review process and how to address major and advisory issues. 

• PRS help resources 
• Frequently Asked Questions (FAQs) 
• Protocol Registration 
• Results Submission 
• Results Module Introductions provide a step-by-step process on entering data for each module within the Results section 
• Protocol Registration & Results Quality Control Review Criteria help users address comments noting major issues and advisory issues on a record, following the PRS review. 

The Responsible Party may delegate ClinicalTrials.gov PRS related duties to their research staff but is ultimately held accountable for the submission and maintenance of their record(s) on PRS, and consequences or penalties for non-compliance. 

Certain Federal agencies/departments and International Committee of Medical Journal Editor (ICMJE ) require a clinical trial to be registered before the enrollment of the first participant.  

NIH and FDA however require registration no later than 21 days after the first participant. 

The ClinicalTrials.gov PRS SOP requires that clinical trials be registered at the time of initial submission on Cayuse. If not, a modification must be submitted prior to enrolling the first participant. 

Records shall be reviewed and verified at least once every 12 months, at minimum (also referred to as record verification).  

Certain data elements must be updated more rapidly, as summarized in the table below. In addition, if a protocol is amended in such a manner that changes are communicated to participants in the clinical trial, updates to any relevant clinical trial information must be submitted no later than 30 calendar days after the protocol amendment is approved by an institutional review board (IRB). 

Data Element	Deadline for updating (all days are calendar days)
Study Start Date	30 days after the first subject is enrolled (if the first participant was not enrolled at the time of registration)
Intervention Name(s)	30 days after a nonproprietary name is established.
Availability of Expanded Access	30 days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record
Expanded Access Status	30 days after a change in the availability of expanded access
Expanded Access Type	30 days after a change in the type(s) of available expanded access
Overall Recruitment Status	30 days after a change in overall recruitment status
Individual Site Status	30 days after a change in status of any individual site
Human Subjects Protection Review Board (IRB) Status	30 days after a change in status
Primary Completion Date	30 days after the clinical trial reaches its actual primary completion date
Enrollment	At the time the primary completion date is changed to ‘actual’ the actual number of participants enrolled must be submitted
Study Completion Date	30 days after the clinical trial reaches its actual study completion date
Responsible Party, by Official Title	30 days after a change in the responsible party or the official title of the responsible party
Responsible Party Contact Information	30 days after a change in the responsible party or the contact information for the responsible party
Device Product Not Approved or Cleared by U.S. FDA	15 days after a change in approval or clearance status has occurred
Record Verification Date	No less than every 12 months, even if no other updated information is submitted at that time

Federally funded clinical trials require that a copy of the IRB approved informed consent form (ICF) be uploaded no less than 60 calendar days from the last study visit. 

ACTs with a primary completion date (PCD) on or after 18 January 2017, require that a copy of the IRB approved study protocol and statistical analysis plan (SAP) be uploaded as part of the results information submission. 

Each document uploaded in the PDF/A format and must include a cover page with the  

• Official Title of the study 
• NCT number 
• Document date (date on which the uploaded document was most recently updated and, if needed, approved by an IRB) 

For more information, visit NLM’s study document upload information. 

The deadline for results information submission is no later than 12 months from the actual primary completion date of the clinical trial. Primary Completion Date is the ‘date the last subject was examined or received an intervention to collect final data for the primary outcome measure’ of the clinical trial. 

Records are usually transferred to another institution when the associated clinical trial and responsible party transfers to a different institution/organization. 

Transfer requests shall be initiated by the Responsible party of the record(s), no later than 30 days from the last day of their service at UTD, via an email to the Clinical Trials Office (CTO), sharing the below details: 

• ClinicalTrials.gov Identifier / NCT number – This is the number that PRS assigned to the record upon its public release. It begins with “NCT” (e.g., NCT12345678). 
• Name of the transfer organization  
• PRS administrator email address at the transfer organization 

Several kinds of issues on a record can trigger it being identified as a ‘Problem Record’. Users shall monitor the ‘Problems’ column to identify records with issues and may receive emails from the PRS.  

Users can access the ‘Problem Resolution Guide’ under Quick Access (top left corner of your account) for help with identifying and resolving these issues. 

There are potential legal consequences for the Responsible Parties if they do not comply with the requirements to submit registration and results information on ClinicalTrials.gov.  The consequences may include civil or criminal actions, civil monetary penalties, and grant funding implications.  Below are some examples: 

FDA 

Public notices of noncompliance and violations, withholding of federal funds, FDA sanctions, and civil money penalties. 

NIH 

Suspension or termination of NIH grant or contract funding and consideration in future funding decisions.  

ICMJE 

Refusal of publication in member medical journals following ICMJE policy. 

The FDA is authorized to seek civil money penalties from responsible parties of ACTs who have either failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov PRS or submitted false or misleading information. 

The FDA initially sends the responsible party a ‘Preliminary Notice of Noncompliance (Pre-Notice) Letter’ describing the potential violation and requests that the responsible party take any necessary actions to address the potential violation within 30 calendar days after receiving the letter.  

The FDA then conducts the review and assessment of the clinical trial information submitted to ClinicalTrials.gov and any other relevant information available to FDA. Failure to comply with the requirements may result in further FDA regulatory action, including the issuance of a Notice of Noncompliance (Notice). If the responsible party still does not remedy noncompliance within 30 calendar days after receiving a Notice of Noncompliance, the FDA generally intends to seek civil money penalties, taking into account the type of noncompliance and the circumstances associated with the lack of remediation. 

For more information on the procedures and penalty amount, refer to FDA guidance Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. 

FDA defines a medical device as ‘An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:  

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them 
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or  
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 

Researchers can utilize FDA’s Device Determination Approaches to determine if their product is regulated by the FDA as a medical device. 

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. 

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations. 

A Mobile Medical Application (MMA) is a mobile app that incorporates device software functionality and meets the definition of a medical device, intended to either: 

• to be used as an accessory to a regulated medical device, or 
• to transform a mobile platform into a regulated medical device. 

For more information, refer to FDA guidance Device Software Functions and Mobile Medical Applications. 

Researchers can also utilize FDA’s tool Digital Health Policy Navigator to determine whether their software might be regulated as a medical device. 

Software functions that meet the definition of a medical device, deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware device are regulated by the FDA as medical devices. The FDA’s policies are independent of the platform on which they might run, are function-specific, and apply across platforms. 

For more information, refer to FDA guidance Device Software Functions and Mobile Medical Applications. 

Researchers can also utilize FDA’s tool Digital Health Policy Navigator to determine whether their software might be regulated as a medical device. 

An investigational device exemption (IDE) is a regulatory process by which the FDA allows an investigational device to be used in a clinical investigation to collect safety and effectiveness data.  

Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. 

Not all clinical investigations of devices require FDA approval of an IDE. Certain clinical investigations that are exempt from an IDE are as below: 

• Clinical investigation of a medical device that is lawfully marketed in the United States. 
• Clinical investigation of a diagnostic device, in compliance with the labeling requirements in 21 CFR 809.10(c) and if the testing: 
  1. is non-invasive, 
  2. does not require an invasive sampling procedure that presents significant risk, 
  3. does not by design or intention introduce energy into a subject, and 
  4. is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. 

• A clinical investigation of device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk. 
• A device intended solely for veterinary use. 
• A device shipped solely for research on or with laboratory animals and labeled in accordance with 21 CFR 812.5(c). 
• A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution. 

Researchers can also utilize NIH’s Decision tree for determining whether their clinical investigation is IDE Exempt. 

Significant Risk (SR) device means an investigational device that: 

• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject, 
• Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject, 
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject, or 
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 

For additional submission requirements, refer to the Investigational Device Exemption (IDE) SOP. 

A Non-significant Risk (NSR) device is one that does not meet the definition for a significant risk device. A Non-significant Risk (NSR) device study can be conducted under the abbreviated IDE requirements up on IRB approval. 

A Non-significant Risk (NSR) device study, as determined by the IRB, is considered to have approved applications for IDE’s, unless FDA has notified a sponsor under 21 CFR 812.20(a) that approval of an IDE application is required. 

Clinical investigations of NSR devices shall be conducted in compliance with the abbreviated requirements listed in 21 CFR 812.2(b). 

Researchers shall attach the completed Non-Significant Risk (NSR) Device Study Determination form to their Cayuse submission for NSR device study. 

Refer to the FDA guidance Significant Risk and Nonsignificant Risk Medical Device Studies, for examples of SR and NSR device studies. 

For additional submission requirements, refer to the Investigational Device Exemption (IDE) SOP. 

REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline data capture for research studies and operations. 

According to FDA’s 2007 Guidance for Industry Computerized Systems Used in Clinical Investigations, if you are conducting a clinical trial and using computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial. 

• Applies to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories. 
• Applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyzer or a Holter monitor to a laboratory information system). 
• Applies to when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading). 
• Does not apply paper records submitted electronically scanned 2 -not to (scanned, faxed copies). 

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Below are the specific criteria, and the associated REDCap feature that meets said criteria. 

Electronic Signature Part 11.3: A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. 

REDCap: Defined by e-signature action 

Electronic Record Part 11.3: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. 

REDCap: E-Record is defined as the form metadata + data entered + e-signature 

Signature/Record Linking Part 11.70: Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. 

REDCap: Defined by record locking process 

Signature Manifestations Part 11.50: Signed e-records shall contain information associated with the signing that clearly indicates: 

1. The printed name of the signer. 
2. The date and time when the signature was executed;. 
3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature. 

REDCap: Defined by e-signature and locking management page 

If your project is using e-signatures for 21 CFR Part 11 projects, the study personnel must adhere to the following requirements: 

1. Before an electronic signature can be established, the study site will verify the identity of the individual. 
2. Each electronic signature will be unique to one individual and will not be reused by, or reassigned to, anyone else. 
3. Persons using electronic signatures shall, prior to or at the time of use, certify to the agency that the electronic signatures in their system are intended to be the legally binding equivalent of traditional handwritten signatures. 
4. Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature. 

REDCap e-signatures are an extension of the record locking/unlocking functionality. Once a data collection instrument has been locked for a given record in the project, a person with e-signature privileges may then apply an e-signature to that form. The e-signature option appears as a check box that says E-signature, which appears just above the Save buttons and immediately below the Locked check box. 

How it works: Although locking a record prevents its data from being modified, the e-signature goes a step farther, and serves as the equivalent of a handwritten signature. If a record has been e-signed, then it denotes that its data has been both locked (to prevent further changes) and authorized (i.e. by a user with e-signature privileges). By default, any user with Lock/Unlock privileges will be able to see the Lock option at the bottom of the data collection instrument, although other users will not see this option. Once a form is locked for a record, the form will display (for all users) the time it was locked and the user who locked it, and all fields on the form will be disabled/read-only until someone with Lock/Unlock privileges unlocks the form. It is also important to note that anyone with locking privileges (even if lacking e-signature authority) will negate the e- signature on a form when unlocking the record, after which data changes can be made to the record. The e- signature can be re-applied after such data changes. For any given record, an e-signature can be saved and negated on a form an unlimited number of times. When saving an e-signature, a user will be asked to enter their username and password for verification. If the username/password verification fails three times in a row, the user will be automatically logged out of REDCap. 

To enable the module, follow the User Rights steps and Record Locking Customization steps below.  

User Rights Steps: 

1. Under the project’s Applications left-hand menu, click on ‘User Rights’. 
2. Click on your username and click ‘Edit User Privileges’. 
3. Scroll to the section ‘Settings pertaining to record locking and E-signatures:’. 
4. Click the box for ‘Record Locking Customization’ and the circle for ‘Locking / Unlocking with E-signature authority’. 
5. Click ‘Save Changes’. 

Record Locking Customization Steps: 

1. Navigate to the project’s Applications left-hand menu and click on ‘Customize & Manage Locking/E-signatures’. 

2. You will see a warning and click on “I understand. Let me make changes”. 

3. For all of the project’s instruments (forms), click the box ‘Display the Lock option for this instrument?’. 

4. Enter text to be displayed when the record is locked in the box ‘Lock Record Custom Text‘. 

5. Click ‘Save’. 

Lock Record Custom Text Example: 

My dated signature confirms that I have personally examined all of the available data recorded for this electronic Case Report Form for completeness and accuracy. 
All information entered by me and/or by my colleagues is correct to the best of my knowledge. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I, 
Principal Investigator of the [UTD Clinical Trial Name] under the auspices of the FDA, intend that this electronic 
signature is to be the legally binding equivalent of my handwritten signature. 
To this I do attest by supplying my username and password and clicking the button marked Save. 

Lock Record Custom Text Example: 

My dated signature confirms that I have personally examined all of the available data recorded for this electronic Case Report Form for completeness and accuracy. 
All information entered by me and/or by my colleagues is correct to the best of my knowledge. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I, 
Principal Investigator of the [UTD Clinical Trial Name] under the auspices of the FDA, intend that this electronic 
signature is to be the legally binding equivalent of my handwritten signature. 
To this I do attest by supplying my username and password and clicking the button marked Save. 

To e-sign and lock a record: 

1. Go to the Form Status section of the form. 
2. Set record status (Incomplete, Unverified, or Complete). 
3. Check the box ‘Lock’. 
4. Check the box ‘E-Signature’. 
5. Click ‘Save Record’. 
6. Enter username and password. 
7. Click ‘Save’. 

To unlock a record: 

1. Click ‘Unlock form’. Note: Previous e-signature is negated, and form will need to be resigned. 

2. Click ‘Unlock’ to ‘Unlock Form’ confirmation message 

3. Enter new data or make changes to record. 

4. Click ‘Save Record’. 

5. Check the box ‘Lock’. 

6. Check the box ‘E-Signature’. 

7. Click ‘Save Record’. 

8. Enter username and password. 

9. Click ‘Save’. 

The table below displays all existing records in the project with their status as locked or e-signed for all data collection instruments. Forms that do not allow locking (if designated on the Record Locking Customization page) will not be displayed below. If a form has been designated not to display the e-signature option but still allows locking, then it will display ‘N/A’ for that form’s e-signature status. You may use the ‘Actions’ links to filter the table in various ways to show or hide rows based on criteria related to its locking or e-signature status. You may click the ‘View Record’ link to view that record on the data collection instrument, which will open in a new window. If you would like to export the table as a file in CSV format, simply click the link “Export all (CSV)”. 

Steps: 

1. Navigate to the project’s Applications left-hand menu and click on ‘Customize & Manage Locking/E-signatures’. 

2. You will see a warning and click on “I understand. Let me make changes”. 

3. Now, click on the tab “E-signature and Locking Management” 

The e-Consent Framework in REDCap enables researchers to create electronic consent forms that participants can complete and sign online. Key features of the e-Consent Framework include: 

• Customizable Consent Forms: Users can design consent forms with various field types, including text, dropdowns, and signature fields, to meet specific study requirements. This customization ensures that all required elements of consent as per ICH GCP guidelines are included. 

• Version Control: The system supports version control, allowing users to manage and present new versions of consent forms as needed while maintaining historical versions for audit purposes. This is crucial for ensuring compliance with FDA 21 CFR Part 11 requirements for document control. 

• Certification Page: A certification page at the end of the survey displays an in-line PDF copy of the completed consent form for participant review and certification. The certification language is customizable to meet specific regulatory requirements. 

• Support for Multi-Form Signing: The e-Consent Framework supports capturing signatures across multiple forms, enabling the collection of signatures from different 

stakeholders. Each form independently uses the e-Consent Framework and generates its own PDF snapshot for the e-Consent portion. 

• Read-Only PDF Snapshot Trigger: When the e-Consent Framework is enabled, it automatically produces a read-only PDF snapshot trigger that saves a PDF copy of the survey response into the project’s file repository. This ensures that all e-Consent documents are archived securely and consistently. 

• Repeatable Instruments and Events: The framework supports repeatable instruments and events, facilitating the management of longitudinal studies. This functionality is critical for maintaining consistency in multi-visit studies as per ICH E6 guidelines. 

• Multi-Language Module (MLM) Support: The framework works seamlessly with the Multi-Language Module, allowing consent forms to be presented and completed in multiple languages, supporting regulatory requirements for non-English speaking participants. 

• Data Access Groups (DAG) Support: The e-Consent Framework supports the use of Data Access Groups, ensuring that data access and permissions are appropriately managed, in line with regulatory requirements for data security and confidentiality. 

The PDF Snapshot feature in REDCap allows for the automatic generation and storage of PDF copies of completed consent forms and other survey responses. Key features of the PDF Snapshot include: 

• Automatic Saving: PDF copies of survey responses can be automatically saved to the project’s file repository or specified fields, ensuring secure and organized storage. This aligns with FDA requirements for data integrity and traceability. 

• Custom Triggers: Users can create custom triggers for generating PDF snapshots based on specific events or conditions, ensuring that snapshots are created at appropriate times during the study. 

• Support for Multi-Form Consents: The PDF Snapshot feature can combine multiple forms into a single PDF snapshot, facilitating the organization and storage of multi-form consents. This supports the FDA requirement for maintaining complete and accurate records. 

• Custom Headers and Footers: The system supports adding custom headers and footers to PDF snapshots, including text fields, smart variables, and piping. This allows for the inclusion of essential metadata, such as participant IDs and timestamps. 

• File Naming Customization: Users can customize the file names of PDF snapshots using static text or piping, appended with the date-time of the snapshot generation. This feature supports regulatory requirements for document identification and retrieval. 

• Audit Trails: The system maintains detailed audit trails for consent form completions and PDF snapshot generations, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and ICH E6. This includes logging actions and maintaining records of who accessed or modified data and when. 

Vault Storage Integration: If the vault (external file storage) is enabled and e-Consent was used in any of the forms, the system can store PDF snapshots in the vault. This functionality is controlled by admin settings at both the system and project levels, ensuring that critical consent documents are securely stored and easily retrievable. 

Click here for guidance. 

Please contact redcap-help@utdallas.edu for further assistance.