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Delegation and training

Who may do what, signed by the PI.

The PI signs every row, and the staff member countersigns.

One log per site, with the full history.

Designed to ICH E6(R3) 2.3.4.

Invite with a link

The staff member gets a link and verifies their identity with MitID.

Multi-level delegation

The right to delegate can also be delegated.

The log as of any date

Changes become new rows, so nothing is overwritten.

The training log follows the protocol.

The attendees and the trainer sign separately.

  • A new protocol version creates training requirements
  • Open requirements appear in the trial calendar

Works with

See the log set up for your study.

Joakim Bo Kunkel

Director, MD, PhD

+45 60 60 17 28