Local coordination

Local Co-ordination
Each participating center will identify a local medical co-ordinator and a local neonatal nurse co-ordinator (as necessary). The responsibility of the local coordinators will be to:

i) be familiar with the trial
ii) liaise with the INIS Co-ordinating center in Oxford
iii) ensure that all staff involved in the care of babies on the neonatal unit are informed about the trial
iv) ensure that mechanisms for recruitment of eligible babies (including information material) are in place, monitor their effectiveness, and discuss reasons for the non-recruitment of any eligible babies with relevant staff
v) ensure that supplies of data collection forms are always available, that they are completed and returned to the INIS Co-ordinating center promptly, and to deal with any queries arising
vi) notify the trial co-ordinating centers of any serious adverse events
vii) facilitate other aspects of local collaboration as appropriate
viii) make all data available for verification, audit and inspection purposes as necessary
ix) ensure that the confidentiality of all information about trial participants is respected by all persons

(INIS Trial - go to protocol)

Duties of the Research Units

CLAP will be the coordinating center for the study. The study coordinator based at CLAP will work with three country coordinators. There will be one country coordinator for each of the following regions: The Province of Buenos Aires, the City of Rosario, and the Department of Montevideo. Each country coordinator will supervise hospital data collectors. A data manager and data entry clerks will also be based at CLAP. The U.S. investigators will support the coordination of the study by distance communications and by frequent in-country visits.

The trial will be directed by a Steering Committee including the Principal Investigator, the Senior Foreign Investigator, CLAP study coordinator, the Statistician, Data Manager, one Data Center representative, and one NICHD representative. The Steering Committee will meet annually, or more frequently as needed. The Steering Committee will be informed on a regular basis of the progress of the study and will provide regular feedback to the investigators and CLAP study coordinators.

(CLAP Trial - go to protocol)

Clinical co-ordination
The clinical co-ordinating centres are in Dundee (Department of Orthopaedics and Trauma Surgery - David Rowley) and Oxford (Nuffield Orthopaedics Centre - David Murray).   At the start of the trial, representatives from these centres will visit all surgeons expressing an interest in collaborating, aiming to get a commitment from collaborating surgeons to recruit to specified comparisons.

Full-time co-ordinating nurses will be based in Dundee and Oxford.  They will:

• support the study nurses in collaborating centres.

• at the start, help to appoint and train study nurses.

• act as a first point of enquiry about any clinical aspect of the trial.

• help the Trial Office to ensure complete data collection (through study nurses) during the initial hospital stay, and following any later hospital admission.

• act as an intermediary between the Trial Office in Aberdeen and study nurses, and have weekly contact with the Trial Office.

• help the Trial Office in connection with any difficulties with later patient follow-up.

• act as local study nurses in Dundee and Oxford.

Arrangements in clinical centres
The trial is designed to limit the extra work for collaborating surgeons to tasks which only they can do.  Study nurses will facilitate the trial locally (see below), and the central organisation will take responsibility for data management and patient follow-up. 

Collaborating surgeons will:

• establish the trial locally (for example by getting agreement from clinical colleagues, facilitating local research ethics committee approval, identifying and appointing a local study nurse, liaising with the local R&D manager, and ensuring that all clinical staff involved in the care of patients having knee replacement surgery are informed about the trial).

• take responsibility for clinical aspects of the trial locally.

• notify the Trial Office of any unexpected clinical event which might be related to trial participation.

• provide support and supervision for all aspects of the work of the local study nurse.

• represent the centre at KAT collaborators meetings.

Each clinical centre will have a part-time study nurse, physiotherapist or other equivalent form of staff, whose number of sessions of employment will depend on the number of patients being recruited in a centre.  Their responsibilities will be to:

• keep local staff informed about the trial and its progress.

• keep regular contact with the local surgeon(s).

• maintain regular contact with one of the co-ordinating nurses (see below).

• identify all those having knee replacement surgery in advance of their admission, and keep a log of whether or not they were recruited to the trial (with reasons for non-participation).

• arrange for the initial letter of invitation and information leaflet to be sent to potential participants and to their GPs.

• assist the surgeon (for example at a pre-assessment clinic) to give additional information and seek consent to trial entry.

• ensure that arrangements are in place for formal trial entry and random allocation, once a participant is admitted for surgery.

• arrange for the GP to be informed about recruitment.

• ensure that the initial data form describing the index hospital admission is completed promptly and sent to the Trial Office.

• collect data describing complications and subsequent admissions to hospital.

• facilitate later follow-up, by for example helping with local tracing.

• assist in the conduct of satellite studies, if applicable.

• provide support for participants in other ways if there are difficulties.

• represent the centre at study nurse meetings.

(KAT Trial - go to protocol)