Medical Records Request for Real-World Evidence Study

Medical Records Request for Real-World Evidence Studies

Real-world evidence (RWE) studies are transforming how medical device manufacturers, regulatory bodies, and healthcare researchers understand device performance and patient outcomes in everyday clinical settings. This Medical Records Request for Real-World Evidence Study template is designed specifically for observational cohort studies that require systematic collection of patient medical records, device usage data, and patient-reported outcomes to support comparative effectiveness analysis and regulatory submissions.

Why Paperform for Medical Device RWE Studies?

When conducting medical device real-world evidence research, coordinating data collection across multiple healthcare providers, patients, and research sites can be overwhelming. Traditional paper-based systems lead to incomplete data, compliance challenges, and delays that can push back critical regulatory timelines.

Paperform transforms this process by providing a secure, professional platform where research coordinators can collect medical records requests, patient consent, and outcome data in one streamlined workflow. Built with SOC 2 Type II compliance and robust security features, Paperform ensures your sensitive health data collection meets the standards expected in clinical research environments.

Who This Template Is For

This template is ideal for:

• Medical device manufacturers conducting post-market surveillance and real-world evidence studies to support FDA 510(k) submissions, PMA supplements, or EU MDR compliance
• Clinical research organizations (CROs) managing observational cohort studies across multiple sites
• Healthcare researchers studying comparative effectiveness of medical devices in routine clinical practice
• Regulatory affairs teams gathering real-world data to support labeling changes, new indications, or safety reporting
• Health economists conducting cost-effectiveness analyses using real-world patient data
• Quality and safety teams monitoring device performance and adverse events in post-market settings

Key Features of This Template

This comprehensive template handles the full spectrum of RWE data collection needs:

Patient Identification & Consent Capture complete patient demographics, study eligibility criteria, and informed consent for medical records release. The form includes specific authorization language for HIPAA compliance and research purposes.

Medical Records Request Details Specify exactly which records are needed—operative reports, imaging studies, lab results, medication lists, and device-specific documentation. This precision reduces back-and-forth with healthcare providers and ensures you receive complete data sets.

Device Information Collection Document the specific medical device(s) under study, including manufacturer details, model numbers, implantation or usage dates, and device settings. This structured data is essential for device-specific cohort analysis.

Patient-Reported Outcomes Integration Beyond clinical records, collect validated patient-reported outcome measures (PROMs) directly from patients. Include quality of life assessments, functional status, symptom severity, and satisfaction scores that complement objective clinical data.

Comparative Effectiveness Framework Structure your data collection to support head-to-head device comparisons, alternative treatment pathways, and outcomes stratification by patient characteristics—critical for value-based care discussions and payer negotiations.

Regulatory Documentation Support Generate the documentation trail needed for FDA, EMA, or other regulatory submissions. Track consent dates, record custodians, data sources, and collection timestamps to maintain audit-ready records.

How Healthcare Organizations Use This Form

Post-Market Surveillance Programs Medical device companies use this form to systematically request records from implanting physicians and hospitals, building robust safety databases that detect signals earlier than traditional passive reporting systems.

Registry-Based Studies Research teams conducting device registries use Paperform to standardize data collection across hundreds of sites, ensuring consistent, high-quality data that can be aggregated for large-scale effectiveness analyses.

Comparative Effectiveness Research Health systems comparing multiple device options for the same indication use this template to gather parallel data sets, enabling evidence-based formulary decisions and clinical pathway optimization.

Regulatory Decision Support When preparing submissions to regulatory agencies, this form helps compile the comprehensive real-world evidence packages that increasingly influence approval decisions, particularly for breakthrough devices and expanded indications.

Automate Your RWE Workflows with Stepper

Once medical records requests are submitted through Paperform, you can use Stepper (stepper.io) to automate the entire follow-up process:

• Automatically route requests to the appropriate healthcare provider or medical records department
• Send follow-up reminders to providers who haven't responded within specified timeframes
• Trigger data quality checks to flag incomplete submissions
• Update your research database or EDC system with new submissions
• Notify principal investigators when specific cohort targets are reached
• Generate compliance reports showing consent coverage and data completeness

This automation means your research coordinators spend less time chasing paperwork and more time analyzing the data that drives better device development and patient outcomes.

HIPAA Compliance and Data Security

Real-world evidence studies handle highly sensitive protected health information (PHI). While Paperform is not HIPAA compliant, it provides SOC 2 Type II security standards and features like SSL encryption, custom data retention policies, and access controls that support secure data collection in research contexts. Organizations should implement appropriate safeguards and business associate agreements as part of their comprehensive HIPAA compliance program.

For studies requiring eSignatures on informed consent forms or records release authorizations, integrate Papersign (papersign.com) to collect legally binding electronic signatures that meet FDA 21 CFR Part 11 requirements for electronic records in clinical research.

Built for Research Coordinators and Clinical Teams

This template speaks the language of clinical research. Field labels use standard terminology from clinical trials and observational studies. Conditional logic ensures patients and providers only see relevant questions based on their device type, study arm, or data collection timepoint. The clean, professional design reassures participants that their data is being collected by a serious research program.

Customize the form to match your study protocol, add your institution's branding, and embed it directly in your research website or patient portal. With Paperform's doc-style editor, non-technical research staff can update inclusion criteria, add new outcome measures, or refine consent language without waiting on IT or developers.

Accelerate Your Real-World Evidence Program

The medical device industry is shifting from pre-market clinical trials to continuous, real-world evidence generation. Regulatory agencies increasingly accept—and sometimes prefer—RWE to answer questions about long-term safety, expanded indications, and comparative effectiveness.

This template helps you build the systematic, high-quality data collection infrastructure that modern device research demands. Whether you're supporting a single investigator-initiated study or a multi-national post-market surveillance program, Paperform gives you the flexibility to adapt quickly while maintaining the rigor that regulators and journals expect.

Start your real-world evidence study with a foundation built for quality, compliance, and efficiency. With this template, you're not just collecting medical records—you're generating the evidence base that improves patient outcomes and advances medical device innovation.