Inside Reg House

What this team does

Gets the study approved by regulators and ethics committees, and keeps it approved.

Files changes, safety updates and yearly reports on time.

Knows which rule applies in which country, or knows who to ask.

A day here

1. 8:30An ethics committee in one country asked for a new translation of the consent form.
2. 10:00Check the tracker. The amendment is approved in four countries and waiting in two.
3. 12:00A site used the new consent form before their committee approved it. You start the fix.
4. 14:30Build the package for a new country: protocol, investigator's brochure, forms, fees.
5. 16:00Read a new guidance from the regulator and write three lines on what it changes for us.

Roles, junior to senior

• Regulatory assistant
• Start-up specialist
• Regulatory affairs specialist
• Regulatory affairs manager
• Head of regulatory

1. Regulatory assistantCollecting documents, formatting and tracking submissions.Regulatory AffairsRegulatory and Essential Records
2. Start-up specialistGetting each new site approved and ready to open.Regulatory AffairsRegulatory and Essential RecordsParticipant Rights
3. Regulatory affairs specialistSubmissions to regulators and ethics committees for a study or country.Regulatory AffairsRegulatory and Essential RecordsParticipant RightsCommunication
4. Regulatory affairs managerThe plan for a product or region and the hard questions from agencies.Regulatory AffairsRegulatory and Essential RecordsQualityCommunication
5. Head of regulatoryStrategy with the agencies and the team that delivers it.Regulatory AffairsRegulatory and Essential RecordsCommunication

Who they talk to every day

• City Hall
• Project Tower
• Safety Watch
• Site 204
• The Exchange

Words you will hear

IND

The US file that lets a sponsor test a new drug in people.

CTA

Clinical trial application. The same idea in Europe and many other countries.

IRB or EC

The ethics committee that must approve a study before patients join.

Amendment

A change to the protocol or consent that needs approval first.

IB

Investigator's brochure. What is known about the drug so far, for investigators.

Essential documents

The papers that show the study was run properly, listed in GCP.

CTIS

The EU portal where trial applications now go.

Common moves in and out

People arrive from site regulatory roles, start-up, quality and science writing.

From here they go to regulatory strategy, quality, medical writing or policy at City Hall.