Standard Operation Procedures
DM 702: Clinical Research Data Management
700    |    701    |    702    |    703    |    SOP Table of Contents

SOP No.: 702   CLINICAL RESEARCH DATA MANAGEMENT

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to:  All CRFs that are developed in conjunction with clinical protocols for the Food and Drug Administration (FDA)-regulated human subject research conducted by Investigators within Thomas Jefferson University’s own facility.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

1. PURPOSE

This procedure describes the processes for the collection and transcription of clinical research data to case report forms (CRFs) or other related forms, and the management of the data, including procedures for quality control, data query resolution, record retention and archiving.

2. GENERAL INSTRUCTIONS

  1. The Investigator is responsible for all aspects of data management and for properly instructing key study personnel on how to collect, transcribe, correct and transmit the data onto CRF or other data collection forms and logs.
  2. The Investigator is responsible for having procedures in place for ensuring that data management activities occur as required by applicable regulations.
  3.  The Investigator is responsible for ensuring that all participating clinical sites have the appropriate tools for and are properly trained in collecting, evaluating, correcting, and transmitting participant data.
  4. The Investigator's Monitor is responsible for examining clinical study data collected and held at the site(s) during monitoring visits.

3. SPECIFIC PROCEDURES

3.1 Collection of Clinical Data

  1. The Investigator will ensure that the clinical protocol describes in detail, appropriate methods for collecting, evaluating, changing, and transmitting participant data.
  2. The Investigator will develop protocol-specific CRF and other appropriate data forms to facilitate the capture of all required study information.
  3. The Monitor will identify site requirements for data collection, storage, transmission and retention during an Investigator's qualification visit.
  4. During the site initiation visit, the Monitor will train key study personnel on proper completion of all CRF and other data forms.
  5. The Monitor also will train key study personnel on proper correction of incorrect data entries.
  6. The Monitor will specify methods for key study personnel to review and/or audit data prior to transmission to the Investigator.

3.2 Data Transcription to CRF

3.2.1 Site CRF Completion Tasks

Key study personnel will be instructed by the Monitor to use the following specific CRF completion procedures:

  1. Ensure that data for the CRF are transcribed in a timely manner from the source documentation
  2. Record all participant data and information in black ballpoint pen on paper CRF
  3. Complete all fields in the CRF according to protocol specifications and site initiation training
  4. Correct errors by striking through the error with a single straight line, making the correction and then dating and initialing the correction
  5. Ensure the original entry is not obliterated by the correction and if necessary, note an explanation or clarification in the CRF margin

3.2.2 General Requirements

  1. An On-Site Query Report Form will be used by the monitor and the investigative site personnel to use as a tool for maintaining an audit trail of clarifications and corrections for a participant's CRF (See SOP 701 Attachment A).
  2. Site personnel should ensure that the Subject Data Clarification Forms are kept with other records in the appropriate study and participant files.

3.3 Data Management, Storage and Retention

  1. The Monitor will assess CRF completion status at each monitoring visit that is conducted during the course of the study, and at the closeout visit when the study is completed or otherwise suspended or terminated.
  2. The Monitor will collect any discrepancies noted at the monitoring visit on his/her own On-Site Query Report Form to ensure an audit trail of clarifications and corrections.
  3. The Investigator 's version and the site's version should be compared to verify they are identical.
  4. The Monitor will advise the site's personnel to keep copies of each On-Site Query Report Form attached to copies of the corresponding CRF and filed with the other study records in the appropriate participant's file.
  5. Errors on the CRF noted at the monitoring visit will be pointed out to the site personnel and corrected by them using the procedures described above prior to the completion of the monitoring visit.
  6. If the Investigator 's designee discovers errors on CRF transmitted between monitoring visits, the designee should contact the site and request that the CRF be corrected as required and resubmitted, and retain a record of the request for correction.
  7. If data management procedures are not being followed, the Monitor will document this, discuss and/or implement corrective actions (e.g., retraining) with the site Investigator, and report all findings to the Investigator.
  8. If sites do not comply with data management procedures on an ongoing basis, the Monitor will document the pattern of non-compliance.
  9. In cases of ongoing non-compliance, the Investigator will institute site termination procedures.
  10. At the conclusion of the study, the Monitor will reiterate regulatory and Investigator requirements for data retention and remind the Investigator to contact the Investigator and request written approval prior to destroying any study-related data.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 11        

Electronic records; Electronic signatures

21 CFR 312.62

Investigator record keeping and retention

21 CFR 812.140

Records

ICH E6, section 2.10

The principles of ICH GCP

ICH E6, section 5.1

Quality assurance and quality control

ICH E6, section 5.5

Trial management, data handling and record keeping

FDA Information Sheets, October 1998

Recordkeeping in clinical investigations.

5. REFERENCES TO OTHER APPLICABLE SOPs

301

Clinical protocol development, implementation and compliance

401

Investigator selection and qualification

402

Initiation visit and site training

503

Documentation and records retention

504

Routine monitoring visits

505

Study closeout visit

701

Case report forms

703

Use of electronic data systems

6. ATTACHMENTS

None

7. DEFINITIONS AND GLOSSARY

The following definitions from 21 CFR 11 and FDA guidance apply to this SOP.

Audit Trail: means a secure, computer generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.

Biometrics: means a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

Certified Copy: means a copy of original information that has been verified, as indicated by dated signature, as an exact copy having all of the same attributes and information as the original.

Computerized System: means computer hardware, software, and associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial.

Digital Signature: means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

Direct Entry: means recording data where an electronic record is the original capture of the data.  Examples are the keying by an individual of original observations into the system, or automatic recording by the system of the output of a balance that measures subject’s body weight.  In these cases, the electronic document is the source document.

Electronic Case Report Form (e-CRF): means an auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.

Electronic Patient Diary: means an electronic record into which a subject participating in a clinical trial directly enters observations or directly responds to an evaluation checklist.

Electronic Record: means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic Signature: means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Predicate Rule: means an FDA regulation that requires the submission to and/or inspection by FDA, of certain data and information relevant to FDA-regulated investigational and/or marketed products. Examples include clinical trial data to support a New Drug Application or device Premarket Approval application.

back to DM-700 index


Click to leave feedback
feedback