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M.P.

Gruppen
Study coordinator Levamisole trial
Academic Medical Centre
Meibergdreef 9
1105 AZ the Netherland

Levamisole Trial
Amsterdam, May 14, 2009 Secretary P.O Box G8-205
Ons kenmerk: MG/rns/2009 Phone number: +31- (0)20- 566 7919
Fax: +31-(0)20- 691 7735
E-mail: levamisol@amc.nl

Audit trail September 2009 results in adaptations to the Levamisole database

A new in log function has been developed: Monitor role. This function is the same as admin user role but
without the possibility to adapt changes and no possibility to appoint users. All edit-roles are redefined in
user-roles. As agreed the adaptations of changes in the database will be done once just before the
analysis.????

A new field has been developed in visit 2: “start date medication”.

In the field Physical examination is asked if a relapse occurred in the past three months. This sentence has
been changed into “how many relapses occurred in the past three months?’ followed by date of relapse 1
(dd-mm-yy) /relapse 2 (dd-mm-yy).

A lock-function was built in the “visit field”.

Kind regards,

Mariken Gruppen,
Study coordinator Levamisole trial

On behalf,

R.A.Scholte(functie…) Dr. J.C.M.A.Davin


Principal investigator
Paediatric Nephrology

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