Research and clinical trial files For research offices, trials units and sponsors
Every study file.
Inspection-ready from day one.
FilePlan 365 gives every research study and clinical trial its own secure file inside SharePoint. Protocols, approvals, consent forms and safety reports are filed to the study they belong to, with the right protection, automatically.
Works inside SharePoint
Study details from your research system
30-day free trial
1
Study details
Study number, title, sponsor and chief investigator, taken from your research management system.
2
Document types
The same labelled folders for every study, down the left.
3
The study’s documents
Everything filed to that study, in the wider panel on the right.
What is FilePlan 365?
A digital filing cabinet, built into SharePoint
Think of a filing cabinet with a drawer for every study, and the same labelled folders inside each drawer. FilePlan 365 does exactly that inside SharePoint, the place your organisation already keeps its documents.
No new system to learn
Your team works in SharePoint and Microsoft 365, just as they do today. There is nothing extra to install on anyone’s computer.
Filed once, found in seconds
Every document goes into the right study file and folder, so anyone with access can find it straight away.
Kept as long as it should be
Each document is protected and kept for the right length of time, without anyone having to remember the rules.
Connected to your research management system
Study details arrive automatically
You never retype a study number, IRAS ID or chief investigator. FilePlan 365 picks up each study’s details from your research management system, so a new study has its file ready the moment it’s registered.
When a study changes
A protocol amendment, a new site or a change of chief investigator is picked up automatically, so every file stays accurate.
When a study closes
The end of study date flows across too, and the clock for how long the file is kept starts by itself.
For your IT team
A Power Automate flow keeps a SharePoint list of studies up to date from your research management system. FilePlan 365 reads that list. No custom code, and it stays inside your Microsoft 365 tenant.
The study file plan
Every study organised the same way
Each study file has the same six folders, so everyone knows where a document belongs and where to find it.
1
Protocol and amendments
Protocol, amendments, investigator brochure
Kept for: 25 years after study end
2
Approvals
Ethics, HRA and MHRA approvals, sponsor sign-off
Kept for: 25 years after study end
3
Consent and participants
Consent forms, information sheets, screening logs
Kept for: 25 years after study end
4
Sites
Site agreements, delegation logs, training records
Kept for: 25 years after study end
5
Safety
Adverse event reports, SUSARs, annual safety reports
Kept for: 25 years after study end
6
Close-out
End of study notification, final report, archiving
Kept for: 25 years after study end
Retention periods are examples. You can match them to your own retention schedule.
Templates
Start with our Research and clinical trial files template. Make it your own.
You don’t have to design a filing system from scratch. The ready-made Research and clinical trial files template gives you the folders, document types and protection settings above in a few clicks. Then change anything you like.
1
Choose the Research and clinical trial files template
Pick “Research and clinical trial files” from the template gallery when you set up FilePlan 365.
2
Use it straight away
Your study files, folders and document types are created for you, ready to start filing.
3
Make it your own
Rename folders, add your own document types, and set how long each is kept, to match your sponsor SOPs and archiving rules.
Find a study
Any study file in seconds
Start typing and FilePlan 365 shows matching studies straight away. No more hunting through folders or asking a colleague where something was saved.
1
Type a few letters
Search by study number, IRAS ID or chief investigator.
2
Narrow it down
Filter by phase, sponsor, status or site if you need to.
3
Open the file
Click a study to see everything filed to it.
People only ever see the studies and documents they are allowed to see.
Advanced search
Answer questions across every study file
Tick a few options and FilePlan 365 finds every matching document across all your studies. Perfect for monitoring visits, regulatory inspections and audits.
Monitoring visitEvery delegation log and training record for one site
MHRA inspectionAll safety reports for one trial
Sponsor auditEvery approval and amendment, in one list
Compliance, without the jargon
Protected and kept for the right time, automatically
FilePlan 365 uses the security and retention tools already in your Microsoft 365, known as Microsoft Purview. You decide the rules once, and they’re applied to every document.
Kept for the right time
Trial files are kept for twenty-five years after the study ends, in line with clinical trial regulations. End of study starts the clock.
Only the right people can see it
Study documents are marked Confidential. Consent forms and participant data are marked Highly confidential.
Participant data stays inside
Documents containing participant identifiers or health data can’t be shared outside your organisation.
These are example settings. You choose the labels and timescales that match your own policies.
Why teams choose FilePlan 365
Less time on paperwork. More time on research.
One file per study
Protocol, approvals, consent and safety, in one place.
Ready on registration
New studies arrive from your research system with their file set up.
Inspections without the panic
Show the full trial master file in seconds.
Archived for you
Retention starts automatically when a study ends.
Every study file.
Always in order.
Try the Research and clinical trial files template free for 30 days, in your own Microsoft 365 tenant.
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