Research Cores - Clinical Research Unit

CRU-3-06 Data Management

SOP:ÌýData Management

Number:
CRU-3-06		 Date:
Version 2.0,
06/Mar/2026		 Supersedes:
Version 1.0,
05/Nov/2024		 Responsible Authority:
CRU Director		 Page 1 of 3

  1. PURPOSE

    The purpose of this SOP is to describe the procedures to be followed for data entry into an electronic data capture (EDC) system and/or clinical trials management system (CTMS) and discrepancy/query resolution for studies conducted in the CRU.

  2. REVISIONS FROM PREVIOUS VERSION

    2.1 ÌýVersion 1.0, 19Sept2024: Initiation of new SOP.

    2.2 ÌýVersion 2.0, 06/Mar/2026: reviewed the SOP, updated version number and date, removed Assistant Director from the SOP, added Research Assistant and CRU staff to the SOP.

  3. POLICY

    N/A

  4. RESPONSIBILITIES

    4.1 CRU Director

    1. 4.1.1 ÌýEnsure that the data collection systems used in the CRU have an audit trail to track changes made to the data once entered into the system.
    2. 4.1.2 ÌýCreate or manage the creation of all new studies in CRU-administered data collection systems.
    3. 4.1.3 ÌýWork with the principal investigator to ensure that all study personnel receive the training necessary to accurately enter data into the EDC and/or CTMS.
    4. 4.1.4 ÌýManage the granting and removal of access privileges to CRU-administered data collection systems for study staff for each study.
    5. 4.1.5 ÌýEnsure that electronic data files stored on the CRU shared drive are only accessible to personnel involved with study conduct.
    6. 4.1.6Ìý Ensure that there is locked cabinet space available for the storage of paper study records for CRU-coordinated studies.
    7. 4.1.7 ÌýFor studies without a data monitoring component, perform periodic data checks to ensure the accuracy and completeness of data entry.
    8. 4.1.8 ÌýAfter the completion of the study, ensure that records are archived according to IRB, sponsor, and Federal requirements.

    4.2CRU Research Coordinator/Research Assistant/CRU staff

    1. 4.2.1 ÌýEnsure that any documents received from or samples taken from participants are labeled with the participant's unique study number; biological samples should also be labeled with the sample number, visit number, and the date and time of sample collection, as applicable.
    2. 4.2.2 ÌýEnsure that no information that identifies study participants is entered into the electronic data capture system or transmitted outside of the institution; identifying information will be entered into the CTMS, but this data will not be transmitted outside of the institution.
    3. 4.3.3 ÌýEnter the data from the source documents into the CTMS and EDC systems within 5 business days, or within sponsor-provided timelines, of the study participant visit or another event.
    4. 4.3.4 ÌýEnsure that any corrections made to the data are documented, with the initials of the person making the corrections, the date of the corrections, and the reason for the corrections.
    5. 4.3.5 ÌýOnce the study data is entered into the EDC and CTMS, properly file the participant's source documents in the participant study binder under the appropriate visit tab and store in locked, limited access area.
    6. 4.3.6 ÌýCheck data against available source documents and respond to data correction requests and make corrections to data within 7 business days, or within sponsor-provided timeline.

    4.3 ÌýPrincipal Investigator

    1. 4.3.1 ÌýEnsure that all personnel granted access to the EDC and/or CTMS have received the necessary training on the protocol and EDC system(s), including any electronic assessment tools being used to collect data in the study.
    2. 4.3.2 ÌýAssign a unique study ID to each participant and maintain the list linking study participant IDs and participant identifying information in a locked storage area with access limited to personnel involved in study conduct.
    3. 4.3.3 ÌýOversee the collection, entry, and correction of all data for the study.
    4. 4.3.4 ÌýEnsure that the data is valid and entered accurately into data management systems.

  5. PROCEDURE

    1. 5.1 ÌýEnsure that data entry systems used in the CRU have audit trail capability.
    2. 5.2 ÌýCreate case report forms in the EDC and build the study in the CTMS.
    3. 5.3 ÌýTrain all study team members who will be entering data on proper use of the EDC and CTMS.
    4. 5.4 ÌýGrant access privileges to all personnel who have been trained and will be entering study data.
    5. 5.5 ÌýAs participants are enrolled in the study, assign the next available study identification number as their unique study identifier.
    6. 5.6 ÌýLabel all study data forms with unique study participant identifier.
    7. 5.7 ÌýWhen source documents are received, enter participant visit data into the EDC and CTMS within 5 business days or other time frame specified by the study sponsor. Do not enter any information that could identify the participant in the EDC.
    8. 5.8 ÌýWhen the mistake is found during data entrance, correct the mistake on paper first before entering the data to the EDC and CTMS. All the corrections should be made with a black ink pen with single line through the incorrect text. Initials of the person making the correction along with the date of the correction should be written by the strikethrough.
    9. 5.9 ÌýDocument corrections to data with initials of person making the correction, date correction made, and reason for correction.
    10. 5.10 ÌýWhen data entry is complete, file the participant's source documents in the participant study binder under the appropriate visit tab.
    11. 5.11 ÌýStore all study documents in a locked, limited access area.
    12. 5.12 ÌýPerform periodic data checks to ensure the accuracy and completeness of data entry.
    13. 5.13 ÌýRespond to data correction requests within 7 business days or within sponsor-provided timeline, checking data against available source documents.
    14. 5.14 ÌýAs studies end or when study team members terminate employment or transfer to another department, remove their access from data collection systems.
    15. 5.15 ÌýArchive records according to IRB, sponsor, and Federal requirements.

  6. REFERENCES

    1. 6.1International Conference on Harmonisation (ICH) Guidelines –Ìý

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

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