CONCEPT #77 OF 100 · Medical, Dental & Clinical Practices · LAYOUT: pleading_caption
Clinical Trial Informed Consent Form (ICF) & FDA GCP Subject Visit Schedule
Standard / Reference: 21 C.F.R. Part 50 (Protection of Human Subjects) · ICH GCP E6(R2) · 45 C.F.R. § 46.116
Why professionals use this template: 17,800/mo search demand: pharmaceutical trial sites and academic medical centers needing IRB-approved 21 C.F.R. Part 50 consent documents detailing dosing schedules, adverse event risks, and visit stipends.
144-DPI VECTOR PREVIEW · PAGE 1 OF 1
ACROFORM READY
Included Financial Metrics & Line-Item Schedule
Target Roles: Clinical Research Coordinators (CRC), Principal Investigators (PI) & IRBs · Search Keywords: clinical trial informed consent form template and subject schedule pdf, fda 21 cfr part 50 informed consent, ich gcp e6 r2 clinical trial consent, irb approved subject stipend schedule
CLINICAL TRIAL PHASE
Phase IIb Randomized
PROTOCOL VISIT COUNT
12 Outpatient Visits
IRB APPROVAL STATUS
Active Thru 12/2026
TOTAL SUBJECT STIPEND
$3,600.00 ($300/Visit)
| CODE | DESCRIPTION & TECHNICAL SPECIFICATION | BASIS / QTY | AMOUNT / DELTA |
|---|---|---|---|
| VIS-01 | Baseline Screening: Physical Exam, 12-Lead ECG, Biomarker Panel & Consent | Visit 1 (3.5 Hrs) | $300.00 Stipend |
| VIS-02..09 | Bi-Weekly Investigational Monoclonal Antibody IV Infusion & Vitals Monitoring | 8 Visits @ $300 | $2,400.00 Stipend |
| VIS-10..11 | Mid-Study Week 8 & End-of-Treatment Week 16 Contrast PET/CT Response Scans | 2 Imaging Visits | $600.00 Stipend |
| VIS-12 | 30-Day Post-Treatment Safety Follow-Up & Pharmacokinetic (PK) Washout Draw | Visit 12 (2.0 Hrs) | $300.00 Stipend |
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