Protocol synopsis

The protocol, the data dictionary, and the consent are settled before enrollment opens, because governance cannot be added later. This page goes with Chapter 7. It is a one-page synopsis you can share with your IRB, your advisors, and your partners, followed by a starter data dictionary.

	Entry
Registry
Condition
Completed by (role)
Date
Version

Synopsis

	Our registry
Title of the registry
Organization and principal investigator (role)
Purpose, and the primary users of the data
Research questions
Who is eligible
Who is not eligible
Case definition and verification tiers
Data sources and schedule
Consent: registry, recontact, data sharing, samples, health record linkage
Global unique identifier: how and when it is assigned
Place for unsolicited information: the open-ended question, and how answers are recorded
Data dictionary: where it is kept, who owns it, current version
Data sharing and access: who decides, and under which agreements
Returning results to participants
Contact and retention plan
Governance: who owns or holds the data under each arrangement, and what happens if the organization or a partner leaves the field
IRB of record, approval number, and date
Version and date of this synopsis

Data dictionary starter

Variable	Meaning	Type	Allowed values and units	Missing codes	Source	Version added

Filled examples from the Lantern Registry

Variable	Meaning	Type	Allowed values and units	Missing codes	Source	Version added
onset_age_months	Age at first seizure	Number	0 to 216, in months; birth recorded as 0	Unknown, declined, not asked	Parent survey at enrollment	1.0
dev_delay	Developmental delay present	Coded	Yes, no, unknown	Declined, not asked	Parent survey, confirmed against clinical note where available	1.0
sz_per_month	Number of seizures in the previous 30 days	Integer	0 or more; values above 300 flagged for review	Unknown, declined, not asked	Seizure diary summary at each follow-up	1.0