SharePoint · Healthcare and life sciences

SharePoint workflow system that takes clinical protocols from draft to regulatory approval

A clinical research organisation moved protocol drafting, review, translation and sign-off out of email and spreadsheets into one SharePoint portal. Every protocol now follows a tracked route from the project manager to the health authority.

Client: A clinical research and bioequivalence study organisation
Industry: Healthcare and life sciences
Platform: SharePoint
Started from: SOP Management product

01The challenge

Clinical and bioequivalence studies run on strict timelines and strict rules. Before this project, the organisation created protocols, collected peer reviews, handled translations, got sponsor sign-off and prepared regulatory submissions through email attachments and spreadsheets. Every protocol needed an English and a local-language version, and it was not always clear which one came first or which file was current. Reviews moved between the project manager, the study coordinator, two medical writing teams, quality assurance and the signatory authorities. Management had no single view of where a protocol was held up or who still owed comments.

02The solution

We built a custom workflow and document system on Microsoft SharePoint Server 2016, hosted on the client's own infrastructure. It was built over 16 to 20 weeks. A project manager creates a protocol and names the team and the signatory authorities. The system then routes it step by step: study coordinator, medical writing teams, reviewers, quality assurance, sponsor, ethics and research committees and the regulatory authority. Authors choose their reviewers on every submission, and quality assurance review is compulsory at each review gate. Every action, file and comment is kept in the protocol history.

How a protocol moves through the system

Create the protocolThe project manager enters the study details, the language, the sponsor and the milestones, and names the team and signatory authorities.
Approve scope and commercialsThe project head and the business head check the study scope, resources and payment milestones.
Assign the coordinatorThe study coordinator receives the approved request and routes it to the medical writing team.
Draft and peer reviewThe author writes the protocol and picks reviewers. Quality assurance review is compulsory, and reviewers can pass work to a second reviewer or ask for changes.
Share with the sponsor and translateThe project manager shares the protocol with the sponsor. The approved file then goes to the translation team, with a second quality review.
Collect signaturesThe coordinator issues the PDF and collects sign-off from both groups of signatory authorities for each language.
Ethics and research committeesThe signed package goes to the ethics and research committees, and their decision is recorded in the system.
Regulatory submission and closureRegulatory affairs submits to the health authority and closes the protocol. The project manager sends the approval letter to the sponsor.

Screens from the system

These screens are redrawn with sample data. No client information is shown.

Screen 1 of 8Built for this client

Project manager dashboard

Pending requests and every protocol with its live status, for the project manager.

What the system covers

Role-based dashboardsPending and approved lists with search and paging for each role, from project manager to regulatory affairs.
Study scopingStudy design, products, sample sizes, periods and washout details captured on one record.
Laboratory and clinical logisticsWho imports products, who buys reference material and how long samples are kept.
Milestones and paymentsProject milestones, percentage splits and amounts, linked to the project head and business head approvals.
Reviewer selection and delegationAuthors pick reviewers on every submission, quality review is compulsory and work can pass to a second reviewer.
Two language tracksEnglish-first and local-language-first protocols, with both documents tracked by version.
Signatory authority matrixEvery protocol lists the team and both groups of signatory authorities with their dates.
Ethics and regulatory gatesCommittee decisions, the regulatory submission and the final sponsor notice are all recorded.

Built with Microsoft SharePoint Server 2016 (on-premises) · Hosted on the client's infrastructure · ASP.NET and C# · SQL Server · Custom workflow engine · Role-based access control · Two-language document management

The result

Every action, file and comment logged with a time and a role, from first draft to regulatory approval
Separate tracks for English-first and local-language-first protocols, so versions never clash
No protocol reaches the sponsor or a committee without full internal sign-off
Each role sees its own pending and approved lists, so everyone knows what is next