ROUGH DRAFT authorea.com/80498
Main Data History
Export
Show Index Toggle 0 comments
  •  Quick Edit
  • MEDIC - participant scheduling and data entry

    [tab:Amendment History]

    |p0.1|p0.2|p0.5|p0.2| Version & Date & Notes & Author 1.0 & 2015-10-07 & Initial version: Guide to collection and entry of MEDIC clinical data & J.Heywood
    2.0 & 2015-10-21 & change FBC references to clinical results after addition of FACS data & J.Heywood
    3.0 & 2015-10-27 & standardise “post” sampling events to “po” (not “PO”) & J.Heywood
    4.0 & 2015-12-01 & blood results treated as per DILfrequency & J.Heywood
    5.0 & 2016-01-13 & change to CDB alias figure & J.Heywood

    Background and Purpose

    Mechanistic Data in Controls (MEDIC) is a longitudinal study of non-T1D participants (hereafter controls) for use as a control population for the DILs clinical studies program. Whilst the primary motivation for the study is for use alongside DILfrequency, it is not restricted to this. Participants are consented under the DIL’s existing ’Genes and Phenotypes’ (G&P) study documentation. As such, the study requires the use of existing database applications from both the ’trial’ scheduling and clinical database domains; this document explaining how to use and record data in both for MEDIC.

    Scheduling

    The scheduling of MEDIC participants is the same as for other DIL Clinical Studies (e.g. DILfrequency). Please refer to the DIL TRIALS recruitment database (TRD) user guide for details.

    Points to note

    The TRD only accounts for a single consent event, whereas participants are consented for every blood sampling event. Individual consent events will be catered for by the CDB, however, please enter the first consent date in the TRD (\ref{fig:Figure_consent_date_TRD}).

    CDB

    Once participants have completed their first visit, data may now be entered into the CDB.

    Participant Record

    1. Open the CDB and open the Volunteer data entry page.

    2. Using the participants name (not forgetting to use ’%’ as a wildcard if you are not sure about spelling etc) and search for them.

      • If the participant does not already exist in the CDB, add a new record and complete the phenotypic and demographic details (name, DOB etc) as normal.

    3. For repeat use of the CDB for MEDIC, you will be able to search using the participant identifier (MED###), provided the aliasing steps (see below) are performed.

    Aliasing

    CDB

    1. Before entering any visit data, enter the MEDIC id (MED###) into the alias table (\ref{fig:Figure_alias_CDB}).

    TRD

    1. To link up participants in the opposite direction, make a note of/copy and paste the CB# from the CDB.

    2. Open the TRD and navigate to the ’Volunteer Register’ screen.

    3. On the left hand side, open the ’STUDY ALIASES’ tab.

    4. Select the ’IP’ study and enter the CB# in the ’Study ID’ column. There is no need for ’Site Affiliation’ (\ref{fig:Figure_alias_TRD}).

    Having entered these aliases once after the first study visit, you may now use the ids to search for participants in both database applications.

    Visit

    Visit data should be entered into the CDB as per other G&P samples. The only differences are:

    1. Choose ’MEDIC’ when opting to enter a new visit (\ref{fig:Figure_visit_use_MEDIC}).

    2. Select the visit type (V1, V1po, etc).

    3. Each individual sampling event is recorded as a separate record. I.e., V1 and V1po count as two separate visits as far as the CDB is concerned (\ref{fig:Figure_visits}). You will be warned when entering a second visit for the same day (Vxpo), but this can be ignored.

    4. Each record should have a separate consent record, but where multiple sampling events occur on the same day, only one questionnaire will apply. Check the questionnaire box for Vx only (i.e., not Vxpo - (\ref{fig:Figure_visit_consent_questionnaire})).

    Study/Tubes

    Visit Study Info should be entered as per other G&P events. Each sampling event should be selected individually and tubes recorded (\ref{fig:Figure_visit_study}).

    Questionnaire

    Enter the questionnaire as per G&P (please note the new tabbed arrangement for the Additional visit data.

    Vital Signs

    Vital Signs are new to MEDIC and can be input independently of the questionnaire. You can enter these for all sampling events if required, but in general will only apply for V1, V2, V3 (Vxpo in general not being recorded) (\ref{fig:Figure_vital_signs}).

    Clinical Results

    Full Blood Count (FBC), immunology/Lymphocyte Phenotype are to be treated in the same manner as DILfrequency - files reported from Pathology are to be sent to DBA for filing, datasets coming latterly.

    \label{fig:Figure_consent_date_TRD} Enter the consent date as the first consent event. The rest will be taken care of in the CDB.