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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
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
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
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
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
Check a protocol against the IRB approval criteria before it is submitted
Check a protocol synopsis against every criterion an IRB must find met before it approves research, including whether figures stated in one section agree with the tables or schedule they summarise, with the citation for each gap
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
Assume everything in the prompt will be seen
Write a hidden prompt on the assumption that a user will eventually read every word of it
Brief an agent so it does not guess
Give an agent enough context to act without inventing the parts you left out
Choose examples that do not skew the answer
Pick and order few-shot examples so the model learns the task rather than the distribution
Define a tool an agent calls correctly
Describe a tool so a model calls the right one, with the right arguments, and recovers when it does not
Give the model the data it needs
Put current, well-shaped data into a prompt without spending the whole context on it
How to instruct a model
Write the instruction half of a prompt so a model follows it
Pick the model the task actually needs
Match a task to a model class rather than reaching for the largest one by default
Prompt a reasoning model
Instruct a model that reasons before it answers, where the habits that help a chat model hurt
Review a prompt before you send it
Check a prompt you are about to send against the rules for writing one a model follows
Review a prompt bound for a reasoning model
Check a prompt against the rules for reasoning models, where chat-model habits work against you
Review a tool definition an agent will call
Check a tool definition for the things that make an agent call it wrongly or not at all
Write an instruction a model follows the first time
Turn a rough request into an instruction a model can act on without a second attempt
Put the instruction first, and fence the material
Write a prompt a model follows on the first try