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Commands that check your consent forms and study documents against what 21 CFR and 45 CFR require, and Frameworks that hold those rules with a citation for each.
Commands that run a check you would otherwise do by hand
Review an informed consent form against 21 CFR 50.25 and 45 CFR 46.116
Check an informed consent form for every required element, with the citation for each gap, before IRB submission
Draft the follow-up letter after a monitoring visit
Draft the follow-up letter to the site from a monitoring visit report, with the rule behind every action item
Review a completed Form FDA 1572 before it goes to the sponsor
Check a completed Form FDA 1572 for every entry it must carry, with the citation for each gap, before it goes to the sponsor
Each one gathers the rules a job needs, from cited sources
Consent exceptions and documentation rules
Hold when informed consent may be waived or excepted, and how consent is documented, on paper or electronically
Device study rules
Hold the duties of sponsors and investigators in a medical device study
Electronic records and signatures rules
Hold the closed-system, signature and password controls that make electronic trial records and signatures trustworthy
Financial disclosure rules
Hold what a clinical investigator's financial interests require to be certified, disclosed and kept
Good clinical practice rules
Hold what ICH E6(R3) asks of investigators and sponsors, from delegation and consent to safety reporting, records and monitoring
IND sponsor and investigator rules
Hold what a drug trial's sponsor and investigators each owe under an IND
Informed consent rules
Hold the rules of informed consent in one place
IRB rules
Hold the rules for who sits on an IRB, how it runs, and what it checks before it approves research
Pediatric research rules
Hold the rules for enrolling children in research, from risk categories to parental permission and assent
Pregnancy and neonate research rules
Hold the rules for research involving pregnant women, fetuses and neonates
Prisoner research rules
Hold the extra protections for research involving prisoners
Every rule in a Framework names the source it was drawn from, and the card links to each source. Check a rule against the text before you rely on it.
Save a card into your own workspace and adapt it to how your team works. The license each source carries is shown on the card.
A Command is a prompt that runs one check, such as reviewing an informed consent form for every element the regulations require. Its card shows a recorded run on an example form.