Childrens Hospital Clinical Research Program Standard Operating Procedures

Guidelines for Data Handling R08

Table of Contents 1. Purpose 2. Objective(s) 3. Definitions and Abbreviations 4. Guidelines and Recommendations Attachments I. Sample Study ID Log II. Sample Screening Log 1. Purpose The purpose of the Data Handling guidelines is to provide guidance to investigators in the procedures for storing and managing data and other documentation used for clinical research. Objective(s) The objective of this document is to provide functional definitions for common data management terms, to provide guidance on the maintenance of study files, regulatory files and source documentation and to provide links to additional resources for obtaining information on documentation and data handling requirements within Childrens Hospital Boston and various federal agencies. Definitions and Abbreviations 3.1 Case Report Form (CRF) a data collection form that is completed by trained research study staff and from which data are keyed onto the database. 3.2 Regulatory Binder (or Files) - is the source that provides a complete and thorough history of the research study from protocol development to study completion. The binder or files include all study-specific information and regulatory documentation including IRB approved protocols, amendments, informed consent, case report forms, FDA 1571 and 1572 if applicable and recruitment materials. 3.3 Source Data information contained within source documents that represent the original documentation of findings and observations of subjects participating in clinical research studies (ICH GCP 1.51) 3.4 Source Documents original documents, data and records such as medical records, laboratory results, x-rays, pharmacy records and subject diaries. (ICH GCP 1.52) Guidelines and Recommendations 4.1 Research Study Files Prior to the start of the study, study staff should prepare a secure location for the storage of study data and supporting documentation. Research records should be locked when not in use with access restricted to authorized staff. Security of
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3.

4.

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Childrens Hospital Clinical Research Program Standard Operating Procedures

research data may include maintaining a locked cabinet within an office, or storage within an office in a clinic that is locked when not in use. The following subsections detail Research Study files maintained for most clinical research studies. Investigators should refer to sponsor-specific requirements for study specific procedures. 4.1.1 Regulatory Binder/Files The regulatory binders or files include all regulatory documentation necessary for the conduct of the study. A designated study staff member should be responsible for maintaining all IRB correspondence, IRB approved protocols, IRB approved informed consents, recruitment materials and other necessary regulatory documents in the files. The organization and sequence of section of the regulatory files may vary depending on the type of the study and is at the discretion of the study staff or the sponsor. The Childrens Hospital Boston Education Quality Improvement Program (EQuIP) provides tools and templates for constructing a study Regulatory Binder. Contact the EQuIP staff and/or visit the EQuIP web page for more information. http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mai npageS2207P5.html Subject Files: Subject files contain all completed case report forms for the subject. If a completed case report form is also considered a source document, a copy of the CRF is filed in the subject files and the original CRF must be filed with other subject source documents. CRFs that will be used as source documents must be signed and dated by the person completing the form. Typically, source documents and subject files are stored separately to avoid the loss of study data and to maintain subject confidentiality. Subject files are generally maintained in chronological order by study visit, but may differ and are at the discretion of the investigator. Study ID Assignment Log: An essential document to be included in research study files that warrants special attention is the study ID assignment log. This log represents the primary source for linking the unique study ID number to subject identifiable information such as name and medical record number. A log of this type may also be known as an enrollment log, subject ID log or screening log. The procedure of assigning a study ID to a subject may take many forms. One typical scenario is as follows: A potential subject is approached for entry in a research study. Informed consent is obtained and criteria necessary for enrollment reviewed. The subject is determined to be eligible. The study coordinator retrieves the study ID assignment log from its secure location. The subject identifiable information is completed on the log in the next available row, thus linking this subject to that study ID number for the remainder of the study.
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4.1.2

4.1.3

Childrens Hospital Clinical Research Program Standard Operating Procedures

Study ID 001-9 002-7 Next Available Study ID 003-4 004-7 005-6

Last name Smith Jones Harris

First Name Susan Thomas John

Date of Birth (mm/dd/yy) 9/13/92 1/20/95 5/25/90

Subject MRN 9999999 1234567 8888888

Date Enrolled (mm/dd/yy) 06/20/03 07/01/03 07/02/03

Assignments of study IDs occur in chronological order. As subjects are enrolled, they are assigned the next available ID on the log. (see Sample Study ID log above) Another scenario to be aware of are studies that require extensive screening processes to determine subject eligibility. For studies such as these, potential subjects may be initially assigned a screening ID number to be used when collecting data to determine eligibility or during the screening phase of the study. The screening log contains information about all potential subjects approached for enrollment in the study and may also include reasons for ineligibility. Only those subjects that meet eligibility requirements will be enrolled in the study and these subjects must then be entered on the study ID assignment log and assigned a final study ID. (See Sample Screening log attachment) Source Documents: Source documents validate study data by confirming that observations recorded on CRFs are accurate and complete, and that study subjects exist. As such, source documentation provides audit trails that allow for the reconstruction and evaluation of a study. The Principal Investigator must establish source documentation requirements prior to the start of the study for each piece of data collected. Examples of source documents include: the subjects medical record, laboratory reports, radiology reports, subject diaries or questionnaires. Sometimes, CRFs are also source documents. If the CRF represents the document in which an observation is first recorded, it is considered a source document (i.e. an interview form including the signature and date of the person conducting the interview). It is often helpful to create a list or log of the sources from which data are to be obtained for each CRF and to maintain instructions for form completion in the study Manual of Operations (MOO). For more guidance on MOOs, refer to Guidelines for Developing a Manual of Operations R05. Source documents
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4.1.4

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are generally filed in chronological order for easy retrieval. Shadow Charts: Shadow charts or research records typically refer to copies of a subjects medical record that is maintained by study staff. The shadow charts generally contain all clinical information related to the subjects care during the research protocol and additional research records that may not be filed in the subjects medical record. The documents contained within these files are NOT considered original source documents, as they are copies. Monitors and FDA auditors may require the original documents or certified copies during site visits or inspections. 4.2 Research Data and Medical Records: Medical Records represent a permanent record of all clinical information pertaining to a patient. As such, once entered, no information can be deleted from a medical record. Thus, it is important for investigators to consider what information, if any, obtained from research should be documented in a subjects medical record. The Childrens Hospital Boston Committee on Clinical Investigations has developed guidelines to assist investigators in determining what information, if any, should be stored in a subjects medical record as it relates to research. The guidance can be found at http://www.childrenshospital.org/cfapps/research/data_admin/Site2206/Documents/ cipp_031_010_rsrch_data_consent_storage.doc. Included in the guidance document are informed consent statements with suggested wording for informing subjects of information that will be made available in their medical records. 4.1.5

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Childrens Hospital Clinical Research Program Standard Operating Procedures

Procedure Attributes
Author: Reviser: Approved: Stavroula Osganian, MD, ScD, MPH / Director Disclaimer: Should Hospital and CRP policies conflict, Hospital policy will supersede CRP policy in all cases. Amy Kroeplin, MPH Tracy A. Antonelli, MPH Date Approved: Annual Review: August 2008 August 2009

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Childrens Hospital Clinical Research Program Standard Operating Procedures

Attachment I - Sample Study ID Log For assistance with Study ID logs and creating study ID numbers, contact the CRP for more information. For more examples of logs refer to the EQuIP website: http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P0.h tml

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Childrens Hospital Clinical Research Program Standard Operating Procedures

Attachment II - Sample Screening Log

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