Case Report Form Sample
What makes the case report form sample legally valid?
Because the world ditches in-office work, the execution of documents increasingly takes place online. The case report form sample isn’t an any different. Handling it using electronic means differs from doing so in the physical world.
An eDocument can be regarded as legally binding on condition that certain requirements are fulfilled. They are especially critical when it comes to signatures and stipulations associated with them. Entering your initials or full name alone will not guarantee that the organization requesting the sample or a court would consider it executed. You need a trustworthy solution, like airSlate SignNow that provides a signer with a electronic certificate. In addition to that, airSlate SignNow keeps compliance with ESIGN, UETA, and eIDAS - main legal frameworks for eSignatures.
How to protect your case report form sample when completing it online?
Compliance with eSignature regulations is only a fraction of what airSlate SignNow can offer to make document execution legal and secure. Furthermore, it provides a lot of opportunities for smooth completion security wise. Let's quickly go through them so that you can stay assured that your case report form sample remains protected as you fill it out.
- SOC 2 Type II and PCI DSS certification: legal frameworks that are established to protect online user data and payment details.
- FERPA, CCPA, HIPAA, and GDPR: major privacy standards in the USA and Europe.
- Dual-factor authentication: provides an extra layer of protection and validates other parties identities via additional means, like an SMS or phone call.
- Audit Trail: serves to capture and record identity authentication, time and date stamp, and IP.
- 256-bit encryption: sends the information securely to the servers.
Completing the case report form sample with airSlate SignNow will give better confidence that the output document will be legally binding and safeguarded.
Handy tips for filling out Case report form sample online
Quick steps to complete and e-sign Case Report Form Sample online:
- Use Get Form or simply click on the template preview to open it in the editor.
- Start completing the fillable fields and carefully type in required information.
- Use the Cross or Check marks in the top toolbar to select your answers in the list boxes.
- Utilize the Circle icon for other Yes/No questions.
- Look through the document several times and make sure that all fields are completed with the correct information.
- Insert the current Date with the corresponding icon.
- Add a legally-binding e-signature. Go to Sign -> Add New Signature and select the option you prefer: type, draw, or upload an image of your handwritten signature and place it where you need it.
- Finish filling out the form with the Done button.
- Download your copy, save it to the cloud, print it, or share it right from the editor.
- Check the Help section and contact our Support team if you run into any problems when using the editor.
We understand how straining filling in forms could be. Get access to a HIPAA and GDPR compliant platform for optimum simpleness. Use airSlate SignNow to e-sign and share Case Report Form Sample for e-signing.
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People also ask
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Who writes the case report form?
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. -
What is a sample case report form?
A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study. -
Who completes the CRF in clinical trials?
CRF completion should only be carried out by the investigator or individuals listed on this form. DEFINITIONS: Case Report Form (CRF): A paper or electronic questionnaire specifically used in clinical trial research. -
What are the two types of CRF?
These two types of CRFs are referred to as single-section and multi-section CRFs, respectively. No matter how many sections comprise a CRF, you view and work on one section at a time. -
Why is CRF important in clinical research?
A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting. -
What is the content of CRF in clinical trials?
3.1. CRF Content Inclusion and exclusion criteria (features a patient needs to fulfil to get enrolled into the study). Demographics (the patient's personal information in an anonymised way). The patient's medical history and the result of the physical examination by the doctor. -
What is a CRF in clinical trials?
What is a Case Report Form? A CRF is a set of documents that collects data and information from a clinical trial. The CRF is used by the study sponsor to capture and retain important data in the clinical trial. CRFs are usually electronic but may also be created in paper form. -
What should be in a case report form?
Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique.
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