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Designing of clinical study documentation -protocol and crf

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Designing of clinical study documentation protocol and crf
Introduction:
The trial documents are both a resource and an outcome; they are the outcome of the study
and a resource for the regulators.
 The regulators cannot observe each trail but would depend on the trail documents and
results to decide whether the new drug or device has an acceptable risk benefit ratio
or not.
Trail master file:
 Guideline E6 states that trail master file should be established at the beginning of the
trail,both at the investigator/institution site and at the sposors office.
 A final close-out of a trail only be done when the monitor has reviewed both the
investigator/institution and sponsor files and confirm that all necessary documents are
in the appropriate files .
 The file maintained at the site is often called the site master file.
 The file is generally the responsibility of a designated member of the investigating
team at the site of the monitor at the sponsors office.
Protocols and their Amendments:
 The master document of the trail is the protocol.
 The Guideline ICH E6 defines the protocol as the document that describes
theobjectives,design,mehtodology,statistical considerations,an organisation of a trail.
 The protocol usually also gives the background and rationale for the trail but these
could be provided in other protocol refrenced documents also.
 In case,if there is an amendment to the protocol,the same should be put up before the
IRB for approval before it is implemented.
 Appendix II (6) of schedule Y to Drugs and Cosmetic rules(2005) implies that all
clinical trails to be carried out as per the conditions laid down in the Decleration of
Helsinki(DOH).
CONTENTS OF PROTOCOL:
 The contents of a trial protocol should generally include the following topics.
However, site specific information may be provided on separate protocol page(s), or
addressed in a separate agreement, and some of the information listed below may be
contained in other protocol referenced documents, such as an Investigator’s Brochure.
General Information:
Designing of clinical study documentation protocol and crf
 Protocol title, protocol identifying number, and date. Any amendment(s)
should also bear the amendment number(s) and date(s).
 Name and address of the sponsor and monitor (if other than the sponsor).
 Name and title of the person(s) authorized to sign the protocol and the protocol
amendment(s) for the sponsor.
 Name, title, address, and telephone number(s) of the sponsor's medical expert
(or dentist when appropriate) for the trial.
 Name and title of the investigator(s) who is (are) responsible for conducting
the trial, and the address and telephone number(s) of the trial site(s).
 Name, title, address, and telephone number(s) of the qualified physician (or
dentist, if applicable), who is responsible for all trial-site related medical (or
dental) decisions (if other than investigator).
 Name(s) and address(es) of the clinical laboratory(ies) and other medical
and/or technical department(s) and/or institutions involved in the trial.
Background Information:
 Name and description of the investigational product(s).
 A summary of findings from nonclinical studies that potentially have clinical
significance and from clinical trials that are relevant to the trial.
 Summary of the known and potential risks and benefits, if any, to human
subjects.
 Description of and justification for the route of administration, dosage, dosage
regimen, and treatment period(s).
 A statement that the trial will be conducted in compliance with the protocol,
GCP and the applicable regulatory requirement(s).
 Description of the population to be studied.
 References to literature and data that are relevant to the trial, and that
provide background for the trial.
Objectives/Rationale/Research Question:
 Include a detailed description of the primary and secondary objectives and the
purpose of the study and clearly state your research hypothesis or your question.
 Discuss the project’s feasibility
 Give details of resources, skills and experience to complete the study.
Designing of clinical study documentation protocol and crf
 Include any pilot study information
Clinical Study Design:
 Primary and secondary endpoints, if any, to be measured during the study.
 Include the information that is needed to answer the research question.
 Include the study design e.g. single, double-blind, observational, randomized,
retrospective etc. A schematic diagram of the study design would be helpful.
 Include the amount of dosage, dosing regimen of the drug, packaging and labelling of
the experimental drug.
 Identify possible benefits of the study.
Inclusion and Exclusion criteria of the Subjects
 Include subjects inclusion criteria.
 Include subjects exclusion criteria. Women of childbearing potential may not be
routinely excluded from participating in research, however, pregnant women should
be excluded unless there is a clear justification to include them.
 Include enrolment of persons of diverse racial and ethnic back grounds to ensure that
the benefits of the research study are distributed in an equitable manner.
Informed consent form process
 Provide information about the regulatory requirements of the consent form and which
languages will be used.
 Include a discussion of additional safeguards taken if potentially vulnerable subjects
will be enrolled in the study e.g., children, prisoners, cognitively impaired and
critically ill subjects.
 Specify Code of Ethics under which consent will be obtained.
 Include a copy of the proposed informed consent along with the protocol.
Adverse Event Reporting
 Describe your plan to report any adverse event.
 Anticipated adverse events should be clearly documented.
 Identify the type and duration of follow up and treatment for subjects that experience
an adverse event.
Assessment of Safety and Efficacy
Designing of clinical study documentation protocol and crf
 Be specific about the efficacy parameters.
 Include the methods and timing for assessing, recording, and analyzing efficacy
parameters.
 Specify the safety parameters.
 Record and report properly all the ad verse events and inter current illnesses.
Treatment of Subjects
 List all the treatments to be administered including product’s name, dose, route of
administration, and the treatment period for subjects.
 Include all medication permitted before and during the clinical trial.
 Include the procedures for monitoring subject compliance.
Data Collection Plan:
 Define the type of data collection instrument that will be used and list all the
variables.
 Specify if computerized databases will be used.
 Identify what software will be used.
 Explain precautionary steps taken to secure the data.
Data Access
 Inform who will have access to the data and how the data will be used. If data with
subject identifiers will be released, specify the person(s) or agency to whom the
information will be released and the purpose of the release.
 Address all study related monitoring, audits, and regulatory inspections.
Statistical Methods
 Describe the statistical methods in detail.
 Include the number of subjects you are planning to enroll. For multi-center studies,
include the total number of sites expected and the total number of subjects to be
enrolled across all sites.
 Provide the rationale for the sample size , the calculations on the power of the trial
and the clinical justification.
 Procedure of accounting for missing, unused and spurious data.
 Procedures for reporting deviations from the original statistical plan.
Designing of clinical study documentation protocol and crf
 Include the selections of subjects to be included in the analyses
Publication and Presentation Plans:
 List any meetings or conference you will be presenting the data and the results of your
study.
Timeline:
 A short paragraph stating when you plan to start and complete the study.
 Include a description e.g. subjects enrolment within a month, data collection within 6
months etc.
References:
 List all the references used in the back ground section at the end of the protocol.
CRF
 CRF is a trial document for collecting and recording, patient-related information in a
standardized and uniform manner. This is important for /the clinical trial team
because the analysis and reporting of trial outcome is largely based on the
completeness and accuracy of data recorded from each patient recruited in the trial.
A good CRF should have the following characteristics:
 It should be clear, systematic and unambiguous.
 It should provide comprehensive instructions to be
followed by investigator to obtain complete information as per approved protocol
and regulatory requirements.
 It should provide guidance on eligibility criteria for the patient to continue in the
trial.
 The design should minimize uncertainties and facilitate entry verification (e.g., cross-
check between related data) by monitor.
 It should facilitate in designing and creating clean database requiring minimum query
resolution between the investigator, monitor and data manager.
CRF DESIGN AND DEVELOPMENT
A good CRF design invites significant contribution and repeated reviewing by expert
team member to meet the objectives. The team consists of:
 CRF designer
Designing of clinical study documentation protocol and crf
 Medical advisor
 Clinical monitor
 Data entry leader
 Data manager
 Statistician
 The CRF designer prepares a frame work based on protocol
 The design should be in accordance with GCP standards and SOP requirements
follow standard format to maintain uniformity.
 As a part of quality control process, the first CRF version thus prepared is checked
against the protocol and for internal consistency by an independent reviewer
 The CRF designer will subsequently generate the second version which is again
reviewed by the team for fine tuning
 The comments on second version are considered for final version which for quality
assurance review and later sent to project manager for approval.
 Once approved, the printer should provide a finished proof copy of the CRF to the
Project manager finally reviews the finished proof copy of the CRP (material,
blinding, format, etc) and orders for printing multiple copies
 . As per GCP guidelines, copies of each version, annotations, review meeting
decisions, quality control/quality assurance checks and all approval documents must
be retained and archived as they represent raw data for the trial.
FORMATTING CRF
 The CRF should be formatted such that repeated observations taken (e,g.,
temperature, blood pressure, pulse etc) can be recorded in separate lines rather than
single line horizontally.
 The units of all measurements should be specified in the CRF to maintain uniformity,
and appropriate boxes should be provided to avoid confusion
 The CRF entries should be neatly written preferably in block letters to avoid errors.
Appropriate space should be provided in each column to avoid overriding,
abbreviations or cryptic comments overflowing the allotted space.
 All text should preferably be 12 point size, which is neither too small not too large.
Moreover the text should be well-spaced with proper page breakup for easy reading.
INSTRUCTIONS FOR CRF COMPLETION
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Designing of clinical study documentation -protocol and crf

  • 1. Designing of clinical study documentation protocol and crf Introduction: The trial documents are both a resource and an outcome; they are the outcome of the study and a resource for the regulators.  The regulators cannot observe each trail but would depend on the trail documents and results to decide whether the new drug or device has an acceptable risk benefit ratio or not. Trail master file:  Guideline E6 states that trail master file should be established at the beginning of the trail,both at the investigator/institution site and at the sposors office.  A final close-out of a trail only be done when the monitor has reviewed both the investigator/institution and sponsor files and confirm that all necessary documents are in the appropriate files .  The file maintained at the site is often called the site master file.  The file is generally the responsibility of a designated member of the investigating team at the site of the monitor at the sponsors office. Protocols and their Amendments:  The master document of the trail is the protocol.  The Guideline ICH E6 defines the protocol as the document that describes theobjectives,design,mehtodology,statistical considerations,an organisation of a trail.  The protocol usually also gives the background and rationale for the trail but these could be provided in other protocol refrenced documents also.  In case,if there is an amendment to the protocol,the same should be put up before the IRB for approval before it is implemented.  Appendix II (6) of schedule Y to Drugs and Cosmetic rules(2005) implies that all clinical trails to be carried out as per the conditions laid down in the Decleration of Helsinki(DOH). CONTENTS OF PROTOCOL:  The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure. General Information:
  • 2. Designing of clinical study documentation protocol and crf  Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).  Name and address of the sponsor and monitor (if other than the sponsor).  Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor.  Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial.  Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).  Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator).  Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial. Background Information:  Name and description of the investigational product(s).  A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.  Summary of the known and potential risks and benefits, if any, to human subjects.  Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).  A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).  Description of the population to be studied.  References to literature and data that are relevant to the trial, and that provide background for the trial. Objectives/Rationale/Research Question:  Include a detailed description of the primary and secondary objectives and the purpose of the study and clearly state your research hypothesis or your question.  Discuss the project’s feasibility  Give details of resources, skills and experience to complete the study.
  • 3. Designing of clinical study documentation protocol and crf  Include any pilot study information Clinical Study Design:  Primary and secondary endpoints, if any, to be measured during the study.  Include the information that is needed to answer the research question.  Include the study design e.g. single, double-blind, observational, randomized, retrospective etc. A schematic diagram of the study design would be helpful.  Include the amount of dosage, dosing regimen of the drug, packaging and labelling of the experimental drug.  Identify possible benefits of the study. Inclusion and Exclusion criteria of the Subjects  Include subjects inclusion criteria.  Include subjects exclusion criteria. Women of childbearing potential may not be routinely excluded from participating in research, however, pregnant women should be excluded unless there is a clear justification to include them.  Include enrolment of persons of diverse racial and ethnic back grounds to ensure that the benefits of the research study are distributed in an equitable manner. Informed consent form process  Provide information about the regulatory requirements of the consent form and which languages will be used.  Include a discussion of additional safeguards taken if potentially vulnerable subjects will be enrolled in the study e.g., children, prisoners, cognitively impaired and critically ill subjects.  Specify Code of Ethics under which consent will be obtained.  Include a copy of the proposed informed consent along with the protocol. Adverse Event Reporting  Describe your plan to report any adverse event.  Anticipated adverse events should be clearly documented.  Identify the type and duration of follow up and treatment for subjects that experience an adverse event. Assessment of Safety and Efficacy
  • 4. Designing of clinical study documentation protocol and crf  Be specific about the efficacy parameters.  Include the methods and timing for assessing, recording, and analyzing efficacy parameters.  Specify the safety parameters.  Record and report properly all the ad verse events and inter current illnesses. Treatment of Subjects  List all the treatments to be administered including product’s name, dose, route of administration, and the treatment period for subjects.  Include all medication permitted before and during the clinical trial.  Include the procedures for monitoring subject compliance. Data Collection Plan:  Define the type of data collection instrument that will be used and list all the variables.  Specify if computerized databases will be used.  Identify what software will be used.  Explain precautionary steps taken to secure the data. Data Access  Inform who will have access to the data and how the data will be used. If data with subject identifiers will be released, specify the person(s) or agency to whom the information will be released and the purpose of the release.  Address all study related monitoring, audits, and regulatory inspections. Statistical Methods  Describe the statistical methods in detail.  Include the number of subjects you are planning to enroll. For multi-center studies, include the total number of sites expected and the total number of subjects to be enrolled across all sites.  Provide the rationale for the sample size , the calculations on the power of the trial and the clinical justification.  Procedure of accounting for missing, unused and spurious data.  Procedures for reporting deviations from the original statistical plan.
  • 5. Designing of clinical study documentation protocol and crf  Include the selections of subjects to be included in the analyses Publication and Presentation Plans:  List any meetings or conference you will be presenting the data and the results of your study. Timeline:  A short paragraph stating when you plan to start and complete the study.  Include a description e.g. subjects enrolment within a month, data collection within 6 months etc. References:  List all the references used in the back ground section at the end of the protocol. CRF  CRF is a trial document for collecting and recording, patient-related information in a standardized and uniform manner. This is important for /the clinical trial team because the analysis and reporting of trial outcome is largely based on the completeness and accuracy of data recorded from each patient recruited in the trial. A good CRF should have the following characteristics:  It should be clear, systematic and unambiguous.  It should provide comprehensive instructions to be followed by investigator to obtain complete information as per approved protocol and regulatory requirements.  It should provide guidance on eligibility criteria for the patient to continue in the trial.  The design should minimize uncertainties and facilitate entry verification (e.g., cross- check between related data) by monitor.  It should facilitate in designing and creating clean database requiring minimum query resolution between the investigator, monitor and data manager. CRF DESIGN AND DEVELOPMENT A good CRF design invites significant contribution and repeated reviewing by expert team member to meet the objectives. The team consists of:  CRF designer
  • 6. Designing of clinical study documentation protocol and crf  Medical advisor  Clinical monitor  Data entry leader  Data manager  Statistician  The CRF designer prepares a frame work based on protocol  The design should be in accordance with GCP standards and SOP requirements follow standard format to maintain uniformity.  As a part of quality control process, the first CRF version thus prepared is checked against the protocol and for internal consistency by an independent reviewer  The CRF designer will subsequently generate the second version which is again reviewed by the team for fine tuning  The comments on second version are considered for final version which for quality assurance review and later sent to project manager for approval.  Once approved, the printer should provide a finished proof copy of the CRF to the Project manager finally reviews the finished proof copy of the CRP (material, blinding, format, etc) and orders for printing multiple copies  . As per GCP guidelines, copies of each version, annotations, review meeting decisions, quality control/quality assurance checks and all approval documents must be retained and archived as they represent raw data for the trial. FORMATTING CRF  The CRF should be formatted such that repeated observations taken (e,g., temperature, blood pressure, pulse etc) can be recorded in separate lines rather than single line horizontally.  The units of all measurements should be specified in the CRF to maintain uniformity, and appropriate boxes should be provided to avoid confusion  The CRF entries should be neatly written preferably in block letters to avoid errors. Appropriate space should be provided in each column to avoid overriding, abbreviations or cryptic comments overflowing the allotted space.  All text should preferably be 12 point size, which is neither too small not too large. Moreover the text should be well-spaced with proper page breakup for easy reading. INSTRUCTIONS FOR CRF COMPLETION
  • 7. Designing of clinical study documentation protocol and crf  The instructions can be presented in the form of instruction manual or instruction page that accompanies CRF.  This includes the general instructions for collecting the data, completion of CRF and dealing with correction of entries made in error.  Date and time format should also be explained at this point. Moreover, the page should also guide to account for missing or unknown data. Graphical representations can be helpful.  Instructions for deviations from CRF items should also be highlighted. FRAMING THE QUESTIONS FOR CRF  It is essential that the questions be framed in a manner that elicits a suitable answer. The question and response formats in a CRF are grouped as follows:  Alphanumeric and free text.  Multiple choice including binary options.  Matrix arrays.  Analogue scales. Alphanumeric and Free Text  This method is used to indicate certain data such as the patient identification adverse event and treatment responses. The responses utilize words and/or numbers. To enter these data, either a free space or constrained space with character separators is provided. Free space gives psychological freedom to the investigator/CRC but, increases the chances of wrong entries, cancellations and re-entries. Character separators ensure that the first entry is the right entry. Multiple Choice Questions  In certain instances like collection of demographic data, it is easier for a CRC/ investigator to tick an answer from the options given rather than writing a self- generated answer. Multiple choice questions are, therefore, the most preferred format of questionnaire that saves time and also reduces the ambiguity. Matrix Arrays  These are utilized to obtain specific information on different categories collectively. The questions are usually arranged in rows and each question has an option from the choices arranged in columns, The options for each question can be ticked. This format provides comprehensive information during analysis Analogue Scales
  • 8. Designing of clinical study documentation protocol and crf  In a clinical trial, it is necessary to asses the progress of the disease or the response to the treatment by comparing the base line observations with the ones observed in the follow-up visits. Analogue scales are often used for some of the assessments. FORMATTING A QUESTIONNAIRE  The questionnaires need to be designed keeping in mind that they are to be filled by patients speaking different languages of different backgrounds, age group, etc. General guidelines:  Use simple and non-technical language.  Use examples wherever necessary.  Minimize free text entry.  The duration of recording in daily card should preferably not exceed 2-4 weeks. Fresh cards are to be provided after two weeks.  Font size should be more than 1.0 to enable comfortable reading by the aged. PACKAGING AND ORGANIZING THE CRF BOOK  Once the final version is ready for printing, it has to undergo a proofreading by at least two members of the team, after which it is approved for final printing.  Ideally three copies should be printed per page considering one for the investigative site, second for the sponsor and third to be used as a worksheet for corrections  The usage of No Carbon Required (NCR) paper is recommended  The CRF can be prepared by doting different types of binding such as:  Stapled  Stitched and glued  Spiral bound  Wire bound  Three ring binder ERRORS IN CRF ENTRY The common errors encountered in the filled CRF are as follows:  Inconsistencies between the source document and CRF  Missing data
  • 9. Designing of clinical study documentation protocol and crf  Inconsistencies across the visits  Illegible data  Spelling errors  Blank 'mandatory comment fields'  Unacceptable terminology  Missing investigators signature Errors identified in the CRF have to be dealt with the help of an query form that is specific to the CRF of the particular study provided by the sponsor. PROCEDURE FOR MAKING CORRECTION IN THE CRF  Query can be generated by the CRA or data entry operator. The identified errors must be discussed by the CRA with the investigator and CRC to obtain the explanation.  The CRC must make the necessary corrections by striking a line through the incorrect entry, entering the correct data with date and initials. The reason for the change has to be explained.  The original entry should not to be whiteout or erased from the CRF as one must be able to see the original incorrect value, i.e. no corrections should obscure the original entry. Refrences:  ICH Guidelines E6 pg no 31-34.  https://www.tgh.org/.../Guidelinesfordesigningaclinicalstudyprotocol.  health.usf.edu/.../Guidelinesfordesigningaclinicalstudyprotocoldoc.pdf  hub.ucsf.edu/protocol-development  https://www.nichd.nih.gov/.../clinicalresearch/clinical-researchers/.../prep..
  • 10. Designing of clinical study documentation protocol and crf