ABSTRACT
The day-to-day running of a clinical study requires the coordinated input from the following specialist groups (see Figure 3.1):
Biostatistics: Statistical Analysis Plan (SAP), study design, randomisation schedule; data tables and listings, difference testing
Study production: Study drug manufacture, packaging, distribution, randomisation
Clinical monitoring: Investigator selection, training, site management, monitoring
Central laboratory: Shipment, analysis, reporting of biological specimens
Pharmacovigilance: Serious Adverse Event (SAE) reporting and quality control (QC)
Data management: Case Report/Record Form (CRF), database/edit check design, data entry and QC
Medical writing: Protocol, clinical study report
Other departments which will contribute to the study on an as-needed basis are:
• regulatory affairs • QA • manufacturing • marketing • preclinical development • drug discovery • medical communications • finance
Matrix Management
The project activities of staff reporting to you will be your responsibility. They are your team, and will look to you for direction. Nevertheless, it will commonly be the case that they have separate line managers, drawn from their own specialities. Indeed they will typically be also working for other project managers in parallel. This is known as matrix management, and in its simplest follows the scheme shown over (Figure 3.2).
