This document provides guidance on the preparation and management of case report forms (CRFs) and patient reported outcome (PRO) forms for clinical trials. It outlines responsibilities for the sponsor, principal investigators, data managers, and monitors. Key points covered include designing clear and logical CRFs, testing CRFs before use, updating CRFs as needed, entering data accurately, and correcting data as required. The purpose is to ensure compliance with regulations and guidelines for collecting study data.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Dale W. Usner, Ph.D., President of SDC, co-authored the article "The Clinical Data Management Process," which was published in the November/December 2014 issue of Retina Today.
The article reviews the clinical data management (CDM) process in its entirety - from protocol review and CRF design through database lock. Describing the roles of various CDM team members and tips for efficient data management practices, "The Clinical Data Management Process" provides a comprehensive yet concise summary of this essential function in clinical trial research, specifically with respect to retina trials.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.
Dale W. Usner, Ph.D., President of SDC, co-authored the article "The Clinical Data Management Process," which was published in the November/December 2014 issue of Retina Today.
The article reviews the clinical data management (CDM) process in its entirety - from protocol review and CRF design through database lock. Describing the roles of various CDM team members and tips for efficient data management practices, "The Clinical Data Management Process" provides a comprehensive yet concise summary of this essential function in clinical trial research, specifically with respect to retina trials.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.
Includes Information about Pharmacotherapeutic of ASTHMA all details about etiology, Pathophysiology, pharmacology, treatment, current clinical trials on ASTHMA etc.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
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Stay informed, stay safe, and get your flu shot today!
micro teaching on communication m.sc nursing.pdfAnurag Sharma
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Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Evaluation of antidepressant activity of clitoris ternatea in animals
case report form crf
1. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 1 of 7
www.norcrin.no
1 PURPOSE
The purpose of this procedure (Standard Operating Procedure - SOP) is to describe the requirements for
the preparation and completion of the case report form (CRF) and patient reported outcome (PRO) forms
for obtaining study-related data in a clinical trial.
This SOP ensures compliance with ICH Guideline for Good Clinical Practice (ICH GCP) and national and
international laws and regulations, specified in the SOP Referansedokument.
2 SCOPE
This SOP is valid for clinical drug trials.
If the sponsor is external, e.g. a pharmaceutical company, the sponsor’s SOPs will be used, provided that
these are in line with national and international laws, regulations and ICH GCP.
3 RESPONSIBILITIES
3.1 SPONSOR
The sponsor has overall responsibility for ensuring that the CRF and PRO forms are prepared and
managed in compliance with this SOP.
The sponsor’s responsibilities shall be described in the governing documents (quality system) of the
individual health facility / the individual institution. Tasks can be delegated. The delegation of tasks shall
be documented.
The national coordinating investigator (for multi-centre studies) or the principal investigator (for single-
centre studies) (NCI / PI) have the responsibility for ensuring that assigned tasks are carried out
according to the requirements of this SOP.
The sponsor will assign the preparation and management of CRF and PRO forms suitably qualified and
experienced individuals.
All staff who carry out these tasks, must possess the necessary qualifications for the task.
If tasks are performed by a third party vendor, in whole or part, this shall be specified in the written
agreement between the sponsor and the third party. The agreement will specify activities to ensure that
the sponsor’s requirements for quality are complied with.
The principal investigator for single-centre studies / national coordinating investigator for multicentre
studies will ensure that appropriate CRF and any required PRO forms (paper or electronic) for the
collection of study-related data are prepared. They will also ensure that the correct version are available
and used by each centre.
The principal investigator for single-centre studies / national coordinating investigator for multicentre trials
must ensure that CRF and PRO are or have been tested or validated before use.
The principal investigator for single-centre studies / national coordinating investigator for multicentre
studies must approve the CRF and any PRO forms before use and approve any amended versions.
The principal investigator is responsible for the correctly completing all required fields in the CRF. This
task may be delegated to other suitably qualified persons. The names and roles of people who have
been assigned the task will be entered into the site specific Delegation Log.
3.2 DATA MANAGERS
Data managers will:
Prepare and test CRFs and PROs
Review data in trial databases
Manage auto and manual query process
2. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 2 of 7
www.norcrin.no
3.3 MONITORS
Monitors will check the accuracy and completeness of CRF entries, source documents and other trial-
related records against each other, including PRO data.
4 PROCEDURES
4.1 GENERAL PRINCIPLES
The CRF and PRO should be designed and completed in order to ensure accurate recording,
interpretation, verification and reporting of data from the study, and shall be in accordance with the
approved protocol.
Data recorded in the CRF and PRO forms should be de-identified, unless otherwise specifically
authorized by the IEC, and a unique identification code (subject number / randomisation number) should
be used for each subject.
The subject ID log/participant log should be stored safely with limited access and separate from the
electronic trial data. If paper CRF is used, separate archive of CRF and subject ID log/Identification and
Enrollment Log should be stored separately if institution procedures requires it. The CRF and PRO must
prevent recording of data that could directly or indirectly lead to the identification of the human subject.
This is especially important for small populations.
If permitted by local regulations, initials, date of birth and gender will be collected.
To ensure uniformity in the collection of data, it is recommended that CRF completion guidelines are
prepared, as necessary. If a new version of the CRF is issued, then the completion guidelines should be
revised and if necessary an explanation of what has changed should be included.
Completion instructions for PROs are usually part of the instrument and separate instructions are not
required.
A blank original (not completed) CRF and PRO are essential documents, according to ICH GCP and
copies must be kept in study file. See SOP Study Files.
There will be additional requirements specific to e-CRF/e-PRO and other electronic systems used in data
collection. See SOP Data Management.
4.2 CRF CONSTRUCTION
The data manager may start work on the design of the CRF before the protocol is finalised. The CRF will
be finalised when the protocol is final and approved by the relevant authorities.
If the protocol is amended during the study and this has an impact on the data to be collected, the data
manager will ensure that the CRF is updated and given a new version number and version date. The
new version must be approved by the NCI / PI before it is sent to the various study centres.
The data manager will ensure that CRFs are easy to use, logically constructed and divided into the
separate study visits described in the protocol.
The data manager will prepare CRFs which consist mostly of multiple forms for each study visit,
continuous forms and final study completion forms. In some studies it is also appropriate to include
follow-up visit forms. A study visit is a visit which occurs while the subject is being administered study
drug as opposed to follow-up visits, which are intended to evaluate long term safety and / or efficacy of
the treatment.
It is usual for adverse events and drug use (concomitant medication) to be collected in modules that are
independent of study visits (continuous forms).
When using a paper CRF, the data manager will ensure that all pages are numbered with the page
number and the total number of pages. Each page shall be clearly marked with the visit identifier or
name (for a continuous form).
3. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 3 of 7
www.norcrin.no
4.2.1 CRF outline
The data manager will ensure that all required modules for a study and the study-specific data are
included in the CRF. The required modules will usually include, but not be limited to the following:
Selection Criteria:
Inclusion criteria
Exclusion criteria
Date of consent
Study visits:
Demography (first visit).
Medical history (first visit)
Study Procedures (tests / examinations)
Response to treatment (laboratory results, CT scans etc.)
Safety variables (laboratory results, etc.)
Handling and administration of study drug (this can also be a continuous form)
If necessary, a signature module for the principal investigator or authorised study personnel to
confirm that the data is complete and correct
Continuous forms:
Documentation of adverse events (Adverse Events, Serious Adverse Events)
Concomitant Medication
Handling and administration of study drug (depending on the study setup)
Follow-up Visits:
Study Procedures (tests / examinations)
Response to treatment (laboratory results, CT etc.)
Safety variables (adverse events incl. Laboratory results etc.)
End of study form:
Date and reasons for study termination
Signature module where principal investigator or sub-investigator confirms that all data are
complete and correct
4.2.2 Construction guidelines
The CRF designer should prepare CRFs which are clear, concise and consistent by ensuring that:
All CRF pages contain fields for recording the study subject's identification code (subject number
/ randomisation number). It is also recommended to have a field for the centre number
The data which is to be recorded and measuring scale / unit to be used, must be clearly and
unambiguously identified
Electronic CRFs include logical checks or minimum / maximum values for the data, if possible
Text fields are used sparingly since textual data is difficult to analyse. If text fields are necessary
the designer should ensure that there is enough space
4. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 4 of 7
www.norcrin.no
Features exist to facilitate coding (drug use, diagnoses and / or adverse events)
Check that the CRF contains exactly the data required by the protocol
There are fields where one can check if procedures are not carried out and / or are not
relevant. If not carried out this should be explained in a separate field
Familiar terminology is used, including established abbreviations, for the relevant discipline
There is no duplication of information
The CRF is dated and version controlled
The person entering data does not need to perform calculations, unless this is absolutely
essential. It is more efficient to perform calculations in the analysis phase of the project.
Standardised font size, colours, headers, etc. are used throughout the CRF
To ensure accurate recording and interpretation of data, it is recommended that the NCI / PI, a data
manager, a statistician and monitor review the CRF prior to its use.
The data manager, the NCI / PI and the statistician if needed should approve the CRF. An email from
each person stating that the CRF is approved can be used to document approval.
4.3 TESTING
Data manager must ensure that the CRF and PRO are tested before use. This should be done by
entering some representative test data (including errors) to the eCRF / DEA.
Testing / validation should be documented and the documentation should include the test data, and
printouts / listings of data and for eCRFs a PDF of the resulting eCRFs.
4.4 UPDATING OF CRFs
If any deficiencies in any parts of a CRF are observed during the study the NCI / PI should ensure that the
developers are requested to make the necessary modifications, while at the same time informing all
centres about the changes. Every effort should be made to schedule CRF development to avoid the need
for design changes once data entry has started.
4.5 DATA MONITORING
Based on a risk evaluation, the monitors may check the accuracy and completeness of CRF entries,
source documents and other trial-related records against each other.
Specifically monitors will verify that:
The data required by the protocol are reported accurately on the CRFs and are consistent with
the source documents.
Any dose and/or therapy modifications are well documented for each of the trial subjects.
Adverse events, concomitant medications and intercurrent illnesses are reported in accordance
with the protocol on the CRFs.
Visits that the subjects fail to make, tests that are not conducted, and examinations that are not
performed are clearly reported as such on the CRFs.
All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the
CRFs.
Monitors will inform the investigator of any CRF entry error, omission, or illegibility.
Data managers will also review data recorded in the database for missing data, inconsistent data, data
outliers. This will be done using automatic and manual queries as defined in the data management plan
for the trial.
5. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 5 of 7
www.norcrin.no
4.6 USE OF PROS
It is recommended that only validated Quality of Life Forms and other validated instruments or
questionnaires forms are used. These often belong to an organisation who owns the copyright and some
organisations charge for use of instruments which they own. The NCI / PI must ensure that requirements
for licenses and copyrights are satisfied.
If it is necessary to use a PRO other than validated quality life questions the NCI/PI should ensure that
the instrument is self-explanatory or if necessary simple instructions should be provided.
4.6.1 Useful links
European Organisation for Research and Treatment of Cancer:
cancer specific quality of life questionnaires and multiple diagnosis specific questionnaire modules for use
with different cancer diagnoses.
RAND Medical Outcomes Study Measures of Quality of Life Core Survey from RAND Health
Use of the SF-12 is governed by Quality Metric, which has no affiliation with RAND (payment is required).
WHO-5 Well-Being Index
4.7 DATA ENTRY INSTRUCTIONS
Instructions can be included in the eCRF or specified in a separate document.
Data managers and CRF designers should consider including the following in the CRF instructions:
4.7.1 Electronic CRF and paper CRF (All CRF types)
Never leave any fields blank. If data is unavailable, enter UN (unknown), NK (not known), MD
(missing data), ND (not done) or other agreed notation. NA (not applicable) should be used only
if the data is not relevant
Be accurate, data should match the source data. If data is subject to interpretation, obtain expert
advice
Only use standard clinical abbreviations
Never write the name or social security number of a subject in the CRF
4.7.2 Paper CRF
Always use a black or blue ball point pen.
If CRF is made of NCR paper, always use an appropriate separator (cardboard / thick paper))
prior to writing on the CRF
Use the fields that are provided, do not write in the margins
Each study visit should be signed and dated by the principal investigator or professionally
qualified person who has been delegated the task, to confirm that all the data reported in CRF
for a subject is complete and correct
4.7.3 Electronic CRF (eCRF)
Never share your user ID and password.
Never store user ID and password in unsecured locations. Try to memorise them so that they do
not need to be kept on paper.
6. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 6 of 7
www.norcrin.no
4.8 DATA CORRECTION
4.8.1 Electronic CRF and paper CRF (all CRF types)
Any change or correction to a CRF should be dated, initialled, and explained (if necessary) and should
not obscure the original entry (i.e. an audit trail should be maintained); this applies to both hand written
and electronic changes or corrections.
Procedures for making corrections to CRF data, or for answering queries (including custom
correction forms) shall be agreed in advance with the principal investigator for single-centre studies /
national coordinating investigator for multicentre studies.
4.8.2 Paper CRFs
Corrections to the sponsor’s copy of the CRF (before the original is sent to the sponsor) will be carried out
as follows:
Cross out the incorrect data by drawing one straight line through the incorrect data, so that the
original data can still be read
Write the correct data in close proximity to the original field
Corrections shall be dated and signed with initials and an explanation of the correction should be
provided if it is not obvious why the correction was made
For example::2009 2010 NBL
Corrections made to CRF data after the original page has been sent to the data manager will be done
using query forms. Query forms are also used to verify data that is outside defined quality standards and
specified limits, or where data are unclear or difficult to read.
The data managers will send queries to the principal investigator who will ensure that the query is
answered. A copy of the completed and signed query form with be attached to the CRF and the original
will be sent to the data manager.
5 DEVIATION MANAGEMENT
Deviation management in a study could be managed according to SOP Protocol Deviation Handling.
All non-compliance should be handled according to the procedures for handling non-compliance of the
individual health facility / institution.
6 REFERENCES
6.1 EXTERNAL REFERENCES
ICH Guideline Good Clinical Practice (GCP) E6 (R2), chapter 4 .9, 5.5.
Good Clinical Data Management Practices Design and Development of Data Collection Instruments.
Reflection paper, on expectations for electronic source data and data transcribed to electronic data
collection tools in clinical trials. EMA 1. August 2010.
6.2 INTERNAL REFERENCES
SOP Data Management
SOP Protocol Deviation Handling
7 ATTACHMENTS
8 DEFINITIONS
Definisjoner
7. CASE REPORT FORM (CRF) AND PATIENT REPORTED OUTCOME
(PRO) FORM MANAGEMENT
Doc. No. LM 2.11
Version No. 3.1
Valid from December 2018. Only the electronic version is valid. Page 7 of 7
www.norcrin.no
9 CHANGES SINCE PREVIOUS VERSION
Version 3.1: This SOP replaces SOP 2.7 version 3.0. Monitoring based on a risk evaluation is included
under 4.5.