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23 Cards in this Set
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Study Files It is suggested that each study team maintain ___ types of separate study files: • ______ Study File/Binder • ______ File/______ for Participants These study files can be maintained as ______ binders or ______ together in ______ large binder. |
It is suggested that each study team maintain 3 types of separate study files: • Regulatory Study File/Binder • Clinical File/Chart for Participants These study files can be maintained as separate binders or compiled together in one large binder. |
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Study Files - Regulatory Suggested Documents/Tabs That Should Be Maintained in the Regulatory Binder/File • Completed Form FDA ______ (Statement of ______) • ______- Approved Documents (Protocol Narrative, Consent Form(s), etc) |
Suggested Documents/Tabs That Should Be Maintained in the Regulatory Binder/File • Completed Form FDA 1572 (Statement of Investigator) |
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Study Files - Administrative Suggested Documents/Tabs That Should Be Maintained in the Administrative Binder/File • _______ Contact Information Guidelines for Handling and Reporting _______ Events Procedures for Handling and Storing _______ Study _______ Information Drug _______, _______, and _______ _______ Report Forms information to be reported to the _______ on each trial subject. |
Suggested Documents/Tabs That Should Be Maintained in the Administrative Binder/File • Sponsor Contact Information Guidelines for Handling and Reporting Adverse Events Procedures for Handling and Storing Laboratory Specimens Study Drug Information Drug Shipment, Dispensing, and Accounting Case Report Forms information to be reported to the sponsor on each trial subject. |
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Study Files - Administrative Suggested Documents/Tabs That Should Be Maintained in the Administrative Binder/File • _______, Telephone Logs, Emails, and Meetings (_______/_______) – Participants _______ Copies of _______ Documents – Original documents, data, and records Log of _______ Visits Master Log of Study _______ Other Related Items That Are Specific For Your Study |
Suggested Documents/Tabs That Should Be Maintained in the Administrative Binder/File • Correspondence, Telephone Logs, Emails, and Meetings (Signed/Dated) – Participants Master Copies of Source Documents – Original documents, data, and records Log of Monitor Visits Master Log of Study Participants Other Related Items That Are Specific For Your Study |
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Clinical File/Chart for Participant A separate binder, file, or chart may be maintained for each participant The following documents/tabs are recommended to be maintained for each participant • Signed _______ Form _______ Report Forms _______ Documents _______ Results _______ Note or Record That the Personnel can use to record the events that occurred at _______ visit Other Related Items That Are Specific For Your Study |
A separate binder, file, or chart may be maintained for each participant The following documents/tabs are recommended to be maintained for each participant • Signed Consent Form Case Report Forms Source Documents Laboratory Results Blue Note or Record That the Personnel can use to record the events that occurred at each visit Other Related Items That Are Specific For Your Study 6 |
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Suggestions for Maintaining Study Files/Binders/Charts Within Each Tab/Category, File the Documents in _______ Date Order File only ____ copy of each document in the proper place • Unless otherwise specified by the _______ or ________ |
Within Each Tab/Category, File the Documents in Reverse Date Order File only 1 copy of each document in the proper place • Unless otherwise specified by the sponsor or Study PI |
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Study Documents – Generally Required by Sponsors This is a list of study documents that a sponsor requires before beginning a clinical trial • Signed IRB Approved _______ and _______ Stamped IRB Approved _______ Form(s) IRB _______ Letter Signed and Completed Form FDA _______ (Drug Studies) Signed _______ Letter (Device Studies) _______ Forms for the PI, Co-Investigators, and Personnel Listed on the Form FDA _______ |
This is a list of study documents that a sponsor requires before beginning a clinical trial • Signed IRB Approved Protocol Narrative and Any Amendments Stamped IRB Approved Consent Form(s) IRB Approval Letter Signed and Completed Form FDA 1572 (Drug Studies) Signed Agreement Letter (Device Studies) Financial Disclosure Forms for the PI, Co-Investigators, and Personnel Listed on the Form FDA 1572 |
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Study Documents – Generally Required by Sponsors This is a list of study documents that a sponsor requires before beginning a clinical trial _______ for the PI, Co-Investigators, and Personnel Listed on the Form FDA _______ Completion _______ for protocol specific training Current Laboratory _______ Laboratory _______ Ranges Signed Contract or Letter of _______ |
This is a list of study documents that a sponsor requires before beginning a clinical trial CVs for the PI, Co-Investigators, and Personnel Listed on the Form FDA 1572 Completion certificates for protocol specific training Current Laboratory Certification Laboratory Normal Ranges Signed Contract or Letter of Agreement |
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Source Documents Source documents are the forms that study team members record _____ and _____. This data is then transferred and reported onto the official _____ or _____which are submitted to the sponsor. Purpose of Source Documents: |
Source documents are the forms that study team members record data and observations. This data is then transferred and reported onto the official CRFs or e-CRFs which are submitted to the sponsor. Purpose of Source Documents: the source documents, which validates the integrity of the data |
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Source Documents Source Documents should include the following information: • Participant _____ • Verification of participant _____ • Documentation of all _____ reported by the participant • Appropriate _____ Documentation |
Source Documents should include the following information: • Participant Demographics • Verification of participant eligibility • Documentation of all adverse events reported by the participant • Appropriate HIPAA Documentation |
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Source Documents Source documents include: • Patient ______ - ______ Data and ______ History - Documentation of ______/______ Eligibility ______ Reports ______ Reports (MRI, ECG, Radiology, Pathology, etc) Documents placed in the patient’s study file to record ______ and ______ by the study team during each visit ______ or ______ forms Study Specific ______ Sheets Study Specific ______ ______ to and from a study subject |
Source documents include: • Patient Chart - Demographic Data and Medical History - Documentation of Inclusion/Exclusion Eligibility Laboratory Reports Procedure Reports (MRI, ECG, Radiology, Pathology, etc) Documents placed in the patient’s study file to record data and observations by the study team during each visit Screening or intake forms Study Specific Flow Sheets Study Specific Checklists Correspondence to and from a study subject |
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Case Report Forms (CRFs) Case Report Forms (CRFs) are used as tools to _______ the collection of study data. CRFs are the “_______” of the study and forms the basis for the _______ of the study. CRFs help to ensure that the _______ of the study met: • _______ Needs • Data _______ Needs There are times when the original collection of data is _______ recorded on CRFs (rating scales, etc). • It is important to note this in the investigator’s study file |
Case Report Forms (CRFs) are used as tools to standardize the collection of study data. CRFs are the “deliverable” of the study and forms the basis for the analysis of the study. CRFs help to ensure that the needs of the study met: • Medical Needs • Data Management Needs There are times when the original collection of data is directly recorded on CRFs (rating scales, etc). • It is important to note this in the investigator’s study file |
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Discrepancies Between Source Documents and CRFs When a discrepancy is found between the CRFs and source documents, the ________ will usually take precedence. If the source document or CRF is corrected, the ________ should sign and date the document and include an ________ as appropriate. • When making a correction, DO NOT USE ________. Place a ________ through the error Make the correction and ________ and ________ (Must be legible) Be sure to check ________ the visits and ________ the visits to see if the same error needs to be corrected ________ cannot make corrections for modifications to source documents or CRFs. |
When a discrepancy is found between the CRFs and source documents, the source document will usually take precedence. If the source document or CRF is corrected, the CRC should sign and date the document and include an explanation as appropriate. • When making a correction, DO NOT USE WHITEOUT. Place a single line through the error Make the correction and initial and date (Must be legible) Be sure to check within the visits and across the visits to see if the same error needs to be corrected Sponsor monitors cannot make corrections for modifications to source documents or CRFs. |
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Discrepancies Between Source Documents and CRFs – Protocol Violations Protocol violations include: • Wrong _______ • Visits _______ of visit windows |
• Participant not meeting the inclusion and exclusion criteria • Wrong diagnosis • Visits outside of visit windows |
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Electronic Data Capture Data are entered into e-CRFs and automated data edit checks alert the study team to any errors in the data entry. • This system provides _______ feedback that can help to educate the study team to prevent similar errors in the future Some sponsors require that a _______ computer is used for data entry for each study. It is in the best interest of the study team to develop a _______ for entering data into the electronic data capture system. |
Data are entered into e-CRFs and automated data edit checks alert the study team to any errors in the data entry. • This system provides immediate feedback that can help to educate the study team to prevent similar errors in the future Some sponsors require that a single computer is used for data entry for each study. It is in the best interest of the study team to develop a system for entering data into the electronic data capture system. |
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Our Goal is to Generate Good, High Quality Data Characteristics of Good, High Quality Data: • Participants meet the ______ criteria • Entries make ______ sense • There are no ______ comments It is a good idea to internal quality assurance reviews after the first ______ or ______ participant visits when beginning the study to correct any errors. • This will help the study team to learn from the errors and prevent future ones. |
Characteristics of Good, High Quality Data: • Participants meet the entry criteria • Entries make logical sense It is a good idea to internal quality assurance reviews after the first 2 or 3 participant visits when beginning the study to correct any errors. • This will help the study team to learn from the errors and prevent future ones. |
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Reasons Investigators and/or Sponsors Discontinue Subjects Medical Reasons _____ adverse events _____ adverse events Participant’s condition _____ Participant develops an _____ other than the one under study during the course of the trial _____ Abnormal _____ values Did not meet original _____ criteria, which was discovered after enrolling onto the study _____ |
Medical Reasons Intolerable adverse events Serious adverse events Participant’s condition deteriorates Participant develops an illness other than the one under study during the course of the trial Pregnancy Abnormal laboratory values Did not meet original entry criteria, which was discovered after enrolling onto the study Death |
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Reasons Investigators and/or Sponsors Discontinue Subjects Patient Compliance and Cooperation Reasons • Use of non-approved _________ medications |
Patient Compliance and Cooperation Reasons • Use of non-approved concomitant medications |
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Reasons Participants Drop Out of Trials They do not understand the ______ of remaining in the study even when their disease condition has improved. The study ______ are too much for them. |
They do not understand the importance of remaining in the study even when their disease condition has improved. The study requirements are too much for them. |
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Suggestions for Maximizing Retention of Participants Try to _______ the time that they have to wait for coming in for their visits. Treat each participant and their family members _______ and with respect. Try to have the same study team _______ at all of the participant’s visits. • This helps the participant to develop a _______ relationship with the study team members. Try not to _______ or _______ the participants through their appointments. • This helps them to feel that they have the opportunity to ask and that the study team wants to answer their _______. |
Try to minimize the time that they have to wait for coming in for their visits. Treat each participant and their family members nicely and with respect. Try to have the same study team members at all of the participant’s visits. • This helps the participant to develop a one-to-one relationship with the study team members. Try not to rush or hurry the participants through their appointments. • This helps them to feel that they have the opportunity to ask and that the study team wants to answer their questions. |
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Suggestions for Maximizing Retention of Participants Give _______ calls and/or emails to the participants 1 or 2 days before their visits. _______ the participant for coming in for their visits and emphasize that the study could not be done without their participation. Give them thank you _______ or _______ for completing the study. |
Give reminder calls and/or emails to the participants 1 or 2 days before their visits. Thank the participant for coming in for their visits and emphasize that the study could not be done without their participation. Give them thank you notes or certificates for completing the study. |
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Helping to Manage Study Compliance When the participant comes in to be consented, it is important for the study team to emphasize the following: They must come in for ______ study visits when they are scheduled and on ______. Must answer all questions ______, especially about their medical and disease histories. They have to cooperate fully with the study ______ and ______. • They can ______ at anytime, but we need them to complete all study tests and procedures in order to obtain the best data possible. Take the study drugs as ______. Ask if anything is not ______ and inform the study team of any ______ that they encountered at home. |
When the participant comes in to be consented, it is important for the study team to emphasize the following: They must come in for all study visits when they are scheduled and on time. Must answer all questions truthfully, especially about their medical and disease histories. They have to cooperate fully with the study tests and procedures. • They can drop at anytime, but we need them to complete all study tests and procedures in order to obtain the best data possible. Take the study drugs as prescribed. Ask if anything is not clear and inform the study team of any problems that they encountered at home. |
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Documenting Non-Compliance When a participant is non-compliant, they need to do the following: • Inform the ______ of the non-compliance issue. • Talk with the participant to understand why they were not compliant and how to ______ it from happening in the future. |
When a participant is non-compliant, they need to do the following: • Inform the sponsor of the non-compliance issue. CRFs. how to prevent it from happening in the future. |
