***DATA MANAGEMENT TIPS FOR INTERVENTIONAL STUDIES***

These data management tips apply to multi-center studies. Investigators
of single-site studies are encouraged to review them and adapt them as
relevant.

***PREPARE***

-   ***Screening Log*** - to capture data on individuals screened,
    including those who are not eligible.

-   ***Study schedule*** -- to identify participant visits and telephone
    calls in a matrix format.

-   ***Written procedures*** - to guide data definitions and collection
    at each participant contact.

-   ***Study forms*** ***(Case Report Forms \[CRFs\])*** - to capture
    all data required by the study protocol.

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-   Utilize numerical response categories in data elements to allow
    summarization and analysis.

-   Avoid redundant data elements and unnecessary data.

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-   ***Adverse event (AE) form*** - to ensure collection of the
    necessary data to generate safety reports.

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-   ***Data Collection Procedures*** - for completing CRFs.

    -   Print neatly and legibly.

    -   Complete all data fields on the CRF.

    -   Write in black ink and press firmly.

    -   Use only participant ID and initials and not the full name and
        chart number of the participant.

    -   Use conventions for missing data (e.g., NA= not available/not
        applicable; ND = not done; UNK= unknown or 97= not available/not
        applicable; 98= not done; 99=unknown).

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-   Provide clear, concise comments and only when necessary.

-   Record dates as specified.

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-   ***Data Handling Procedures --*** to describe how data are entered
    into a computer system (e.g. at study site or transmitted to
    Coordinating Center for central entry) and tracked from collection
    through entry.

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-   ***Clinical data management system (CDMS)*** -- typically a computer
    system for data entry, editing, storage, and transmission to an
    analysis package. Include:

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-   ***Edit Processes*** -- check for missing, inconsistent, and
    erroneous entries; describe data correction processes and tracking
    changes.

-   ***Participant Status --*** method or codes that track the ***status
    of each participant*** throughout the study.

-   ***Laboratory Data -*** describe process for obtaining,
    transmitting, and reconciling laboratory data.

-   ***Data Management Reports*** -- routinely describe study progress
    and data quality.

-   ***Final, Cleaned Data Set*** -- mechanism to ensure it is created
    and archived when the study has completed.

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-   ***Data Sharing Policy*** - identify considerations for sharing the
    final data set.

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-   ***Confidentiality Mechanisms*** -- to ensure that the Health
    Insurance Portability and Accountability Act (HIPPA) guidelines are
    followed to protect the confidentially of participants' data and to
    establish a convention for unique participant identifiers (PIDs).

-   ***Follow-up Procedures*** -- describe procedures for ***following
    participants*** from enrollment through study completion.