A Datacapt study setup follows the same ten steps whether you run a 30-subject cosmetic test or a 600-subject trial. Steps 1 to 3 are the platform's foundations and you do them once. Steps 4 to 10 repeat for each study.

The ten steps

#	Step	Who	Guide
1	Create your centers. The abbreviation enters every subject ID	Platform admin	Create and manage centers
2	Define your roles and their permissions	Platform admin	Roles and Permissions Management
3	Invite your users to the platform	Platform admin	Invite and manage platform users
4	Create the study and choose its settings: subject ID pattern, date format, GCP, eCRF Review, personal information	Project manager	Set a Subject ID Pattern, Modify the date format, Enable and use the "reason for change option"
5	Build the eCRF: structure, questions, calculations, conditions, validations	Data manager	Build, test and publish an eCRF, Calculation recipes, Data validation recipes
6	Add the modules the protocol needs: eConsent, ePRO, randomization, kit allocation, medical coding	Data manager	The "What … is, and how it works" article of each module
7	Translate the study content for each country	Data manager	Configure translations for multi-language studies
8	Set up automations: notify the monitor of an inclusion, send an ePRO after a visit	Project manager	Create and Configure Automations
9	Invite the study team and test as each role on test subjects	Project manager	Invite and manage users in a study
10	Run the go-live checklist and set the study Live	Project manager + quality	Go-live checklist

💡 Tip: start step 5 from a template when you have run a similar study. Demographics, vital signs, adverse events and concomitant treatments change little between protocols. See Save and reuse eCRF templates.

Which guide for which role

You are	Start with
Investigator or study nurse	Complete an eCRF visit, Include a subject and open their eCRF, Raise, answer and close a query, Lock and sign eCRF data
Monitor (CRA)	What data monitoring covers in Datacapt, Review forms and mark data as SDV, Declare and track missing data
Data manager	Build, test and publish an eCRF, Name your variables and predict your export columns, Build automated queries with data validation, Export eCRF data
Medical coder	What medical coding is, and how it works in Datacapt, Code verbatims against a dictionary
Project manager	This page, Update a study's status, Track eCRF completion across subjects, Build study reports
Platform administrator	Invite and manage platform users, Roles and Permissions Management, Set up and use Single Sign-On, Read the platform audit trail
Quality or regulatory lead	Prepare for a regulatory inspection or a sponsor audit, Follow eCRF best practices, Read and export the study audit trail
Recruitment team	Recruitment - General information, Configure a recruitment study, Managing participant availability & washout
Developer	Create a personal API key, Set up and use the Datacapt MCP (Beta)

👉🏻 Next step

Create and manage centers

Build, test and publish an eCRF

Go-live checklist

Set up a study from protocol to first patient: the roadmap

The ten steps

Which guide for which role

👉🏻 Next step