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AI Tools for Clinical Research Coordinators
AI tools for protocol research, regulatory guidance, clinical trial discovery, patient education, and regulatory documentation preparation.
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SAE Reporting — Fatal/Life-Threatening
Immediate report required (same day or next business day)
SAE Reporting — Other Serious
Report within 15 calendar days of awareness
IND Safety Reports
21 CFR 312.32 — sponsor must notify FDA and all investigators
Required SAE Content
Event description, date, causality, action taken, outcome
Record Retention
Study records retained 2 years post-NDA approval or IND closure
Patient recruitment and trial matching
Identify eligible patients and find clinical trials matching their diagnoses and demographics. Support patient enrollment in relevant research.
Our clinic has patients with early Alzheimer's disease interested in research. Find recruiting trials testing disease-modifying therapies nearby.
Found 12 recruiting trials for early Alzheimer's within 100 miles. Trials testing monoclonal antibodies (2), cognitive interventions (1), combination therapy (1), exercise-based (3), etc. Closest site 15 miles away. Eligibility varies - some require amyloid positivity, others don't. Provided links for patient review and contact information.
ToolRouter search_trials
NctIntervention typePhase
NCT05209932Cognitive training2
NCT05044377Exercise-based2
NCT05617884Mindfulness + sleep2
12 recruiting trials · 3 non-drug within 100 mi
Protocol and regulatory research
Research FDA guidance, ICH-GCP guidelines, and regulatory requirements for clinical trial conduct and documentation.
Our protocol requires reporting adverse events to the FDA. What are the specific timelines and requirements for serious adverse event reporting?
FDA requirements: Serious adverse events MUST be reported IMMEDIATELY (same day/next business day) if life-threatening or fatal. Non-serious serious events within 15 days. SAE report must include: event description, date, relationship to study drug, actions taken, outcome. Provide to Sponsor (who reports to FDA). Keep copy in study file for audit trail.
ToolRouter research
Fatal / Life-Threatening
Immediate — same day or next business day
Other Serious Events
Within 15 calendar days of awareness
Non-Serious AEs
Periodic reports per protocol schedule
Required Elements
Event, date, drug relationship, actions taken, outcome
Audit Trail
Copy in site study file required for inspection
Patient informed consent and education
Create comprehensive patient education on study protocol, risks, benefits, and alternatives. Support informed consent process.
Create patient education materials for a cardiovascular drug trial. Explain: study purpose, what participation involves, potential risks, benefits, alternatives, data privacy.
Generated 4-page patient education: study objectives in plain language, participation timeline and visits, procedures patient will undergo, known risks and possible unknown risks, benefits (direct and research contribution), alternatives available, data security and privacy measures, right to withdraw, contact information for questions.
ToolRouter repurpose_content
Study Objectives
Plain-language summary of research goals
Participation Timeline
Visit schedule, procedures, and what to expect
Known Risks & Benefits
Side effects, direct and indirect benefits listed
Data Privacy
HIPAA protections and data security explained
Right to Withdraw
Voluntary participation, no-penalty withdrawal stated
Study documentation and compliance
Research regulatory requirements for study documentation, data handling, and audit readiness to ensure compliance.
We're preparing for an FDA audit. What are the essential documents and records we must have in the study file?
Essential study file documents: protocol and amendments, informed consents (signed), case report forms (patient visit records), serious adverse event reports, study drug accounting records, lab/imaging results, correspondence with sponsor and IRB, quality overall summary. Must be organized, accessible, and audit-ready. FDA expects complete file within 30 days of request.
ToolRouter research
Protocol & Amendments
All versions with IRB approval letters
Signed Informed Consents
One per patient per consent version
Case Report Forms
Patient visit records — complete and legible
SAE Reports & Correspondence
Sponsor and IRB notifications on file
Drug Accountability Log
Receipt, dispensing, return, and destruction records
Ready-to-use prompts
Trial matching
Find clinical trials for a 75-year-old with mild cognitive impairment who is interested in non-drug cognitive interventions. What trials are recruiting?
Adverse event reporting
Research the regulatory requirements for reporting adverse events in a clinical trial sponsored by a pharmaceutical company. What are the timelines?
Patient education
Create patient education materials for a 6-month clinical trial of a new diabetes medication. Include: study purpose, schedule, potential side effects, benefits, withdrawal options.
Protocol compliance
Research GCP (Good Clinical Practice) guidelines for informed consent requirements in clinical trials. What must be documented?
Tools to power your best work
Deep ResearchAI research reports with citations
Clinical TrialsClinical trials & drug safety data
165+ tools.
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Everything clinical research coordinators need from AI, connected to the assistant you already use. No extra apps, no switching tabs.
New trial site initiation
When initiating a new trial at your site, research protocol, regulatory requirements, and prepare patient education materials.
Patient recruitment
Identify potentially eligible patients and match them to clinical trials, support enrollment process.
Frequently Asked Questions
How do I ensure my site stays compliant with regulatory requirements?
Maintain thorough documentation, follow protocol rigorously, report all adverse events promptly, maintain adequate training records. Regular internal audits help identify issues before FDA inspection. Build a compliance culture on your research team.
What's the best approach to recruiting diverse patient populations for trials?
Partner with community organizations, use diverse recruitment channels, ensure materials are culturally appropriate and accessible. Address barriers to participation. Research shows diverse recruitment requires intentional effort and community engagement.
How detailed should patient education materials be?
Match the complexity to your patient population's literacy level. All materials should be reviewed for plain language understanding. Most IRBs recommend 8th-grade reading level or below. Include visuals when possible. Patient feedback improves materials.
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