CRF Modules and Guidelines Table
| CRF Module/Guideline Name | CRF Module/Guideline Description | Version
Number | Version Date | Disease | Domain | Sub-Domain |
|
Adverse Events
| The Adverse Events (AEs) CRF Module documents medical events that occur to a participant/subject once enrolled in a study. The AE form includes: the AE start date, severity, relatedness, outcome, and an indication of whether the event is serious. |
3.0
| 11/6/2008 | General (For all diseases) | Safety Data | Adverse Events |
|
Death Report
| The Death Report CRF Module should only be completed in the event of the participant's/subject’s death while enrolled in the study. It captures the date, time and the medical reason death is attributed. |
2.0
| 3/17/2008 | General (For all diseases) | Outcomes and End Points | End Points |
|
Demographics
| This CRF Module contains data elements that are collected to describe the demographics of the study population. The items are used to compare baseline characteristics among study groups and to identify confounding variables. |
3.0
| 11/6/2008 | General (For all diseases) | Participant/Subject Characteristics | Demographics |
|
Electrocardiogram (ECG)
| The Electrocardiogram (ECG) CRF Module is used to document the time, date, and results of this cardiac function test. |
1.0
| 11/6/2008 | General (For all diseases) | Assessments and Examinations | Non-Imaging Diagnostics |
|
Laboratory Tests
| Laboratory tests are routinely administered in clinical trials of pharmacological interventions to assess participant/subject safety and an individual’s eligibility for study. This CRF Module can be used to collect the laboratory test results.
|
2.0
| 3/17/2008 | General (For all diseases) | Assessments and Examinations | Laboratory Tests and Biospecimens/ Biomarkers |
|
Medical History - Review of Systems at Baseline
| Medical History data are collected to verify the inclusion and exclusion criteria (e.g., no history of cognitive disabilities) and to describe the study population. The Medical History CRF Module captures conditions that EVER occurred at some point in time within a protocol-defined period (e.g., the last 12 months). |
3.0
| 11/6/2008 | General (For all diseases) | Participant/Subject History and Family History | General Health History |
|
Participant/Subject Contact Information
| The Participant/Subject Contact Information CRF Module records the contact information for the study participant/subject. The template form also has a place to record the contact information for persons who regularly interact with the subject. The contact information data are not part of the clinical data management system so as to protect the identity of study participants, but rather are kept in a locked location for authorized study personnel to reference.
|
2.0
| 3/17/2008 | General (For all diseases) | Protocol Experience | Study Management |
|
Physical Exam
| The physical exam is generally administered at screening and/or baseline to determine study eligibility. It may also be administered at follow-up visits to track a participant's/subject’s physical status. This CRF Module captures the physical exam results. |
2.0
| 11/6/2008 | General (For all diseases) | Assessments and Examinations | Physical/ Neurological Exam |
|
Prior and Concomitant Medications
| Collecting medications taken prior to the study in a defined time window (e.g. 30 days) is important when there may be potential interactions with the study intervention. The Prior and Concomitant Medications CRF Module should be filled out at all visits throughout the study period. |
3.0
| 11/6/2008 | General (For all diseases) | Treatment/Intervention Data | Drugs |
|
Rankin Scale (Modified)
| The Modified Rankin Scale (mRS) is a measure to assess the degree of global function or disability in patients. |
3.0
| 11/6/2008 | General (For all diseases) | Outcomes and End Points | Global Outcomes |
|
Screening Log
| The Screening Log is an essential document that records all individuals who entered pre-screening or screening. It details the reasons why an individual was not enrolled or provides the enrollment date if he/she was enrolled into the study. It is also an effort to capture the screening barriers and issues related to enrolling participants/subjects into the clinical study protocol. |
2.0
| 3/17/2008 | General (For all diseases) | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
|
Study Discontinuation / Completion
| The Study Discontinuation/Completion CRF Module captures each participant's/subject’s status at the end of the study. It provides an anchor for quality control and analysis. The status, in aggregate, also defines the study population -- those completed, lost, etc. |
3.0
| 11/6/2008 | General (For all diseases) | Protocol Experience | Off Treatment / Off Study |
|
Visit Checklist
| The Visit Checklist is an administrative tool used to make sure all scheduled assessments/events are done at a particular study visit/time point. |
2.0
| 3/17/2008 | General (For all diseases) | Protocol Experience | Study Management |
|
Visit Schedule
| The Visit Schedule, is a matrix that documents when each of the study assessments/events take place over the course of the study. The assessments/events are listed down the page as rows and the visits/time points are listed across the page as columns. This is an administrative tool that can be used by the study. |
2.0
| 3/17/2008 | General (For all diseases) | Protocol Experience | Study Management |
|
Vital Signs, Weight and Height
| This CRF Module captures vital signs, weight, and height. Vital signs can help assess the safety of the intervention and monitor the health of the participants/subjects throughout the study period. Height and weight are commonly collected at the baseline visit. |
3.0
| 11/6/2008 | General (For all diseases) | Assessments and Examinations | Vital Signs and Other Body Measures |
|
Family History at Baseline
| The Family History at Baseline CRF Module captures data about whether a specific list of diseases/conditions run in the participant's/subject's family (i.e., blood relatives only). |
3.0
| 11/6/2008 | General (For all diseases) | Participant/Subject History and Family History | General Health History |
|
Inclusion and Exclusion Criteria
| The Inclusion and Exclusion Criteria CRF Module specifies the characteristics of potential study participants/subjects that must be met prior to enrollment. All Inclusion Criteria must be answered YES and all Exclusion Criteria must be answered NO or N/A in order for the subject to be considered eligible for study participation. |
3.0
| 11/6/2008 | General (For all diseases) | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
|
Laboratory Tracking
| The Laboratory Tracking CRF Module is used to track labs sent to a laboratory that then electronically transmits the results to the site or coordinating center database. It provides a mechanism for reconciling labs sent with those received electronically from the laboratory. |
2.0
| 3/17/2008 | General (For all diseases) | Assessments and Examinations | Laboratory Tests and Biospecimens/ Biomarkers |
|
Protocol Deviations
| This CRF Module records any protocol deviations that may occur during the study for a given participant/subject. |
2.0
| 3/17/2008 | General (For all diseases) | Protocol Experience | Protocol Deviations |
|
Serious Adverse Events
| The Serious Adverse Event (SAE) Report is used to provide detailed information about each SAE that occurs during the study. It contains the information MedWatch, the FDA Safety Information and Adverse Event Reporting Program, requires for reporting SAEs. |
2.0
| 3/17/2008 | General (For all diseases) | Safety Data | Adverse Events |
|
Study Drug Dosing
| This CRF Module tracks the study intervention dosing regimen for an individual participant/subject across the duration of the study in a log format. For each dosing record the Start Date, Stop Date, Dose Amount, Dose Unit, and Dose Frequency are recorded. |
2.0
| 3/17/2008 | General (For all diseases) | Treatment/Intervention Data | Drugs |
|
Trail Making Score
| The Trail Making Test (TMT) is a reliable assessment of attention, sequencing, cognition, visual search, and motor function. |
3.0
| 11/6/2008 | General (For all diseases) | Outcomes and End Points | Global Outcomes |
|
Coriell's Control Data Elements
| The NINDS Human Genetics DNA and Cell Line Repository maintained by the Coriell Institute for Medical Research (Coriell) requires certain data elements be collected for the genetic samples that are banked for controls. This CRF Module includes those elements and can be found on Coriell's Web site. |
1.0
| 1/18/2010 | General (For all diseases) | Assessments and Examinations | Laboratory Tests and Biospecimens/ Biomarkers |
|
Informed Consent and Enrollment
| It is important to collect the date of certain study milestones, such as informed consent, study enrollment and randomization, from both an administrative and human subjects' protection standpoint. This CRF Module captures those key pieces of data. |
1.0
| 11/6/2008 | General (For all diseases) | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
|
Study Drug Compliance
| The Study Drug Compliance form tracks the expected (i.e., prescribed) vs. actual use of the study drug by an individual participant/subject. |
1.0
| 3/17/2008 | General (For all diseases) | Treatment/Intervention Data | Drugs |
|
Surgical History at Baseline
| This CRF Module collects surgical history data that are collected to verify the inclusion and exclusion criteria and to describe the study population. The collected data should focus on surgical or invasive interventions that are clinically relevant to the study protocol. |
3.0
| 11/6/2008 | General (For all diseases) | Participant/Subject History and Family History | General Health History |
|
Behavioral History at Baseline
| This CRF Module is for studies that need to collect information related to tobacco and alcohol use. |
3.0
| 11/6/2008 | General (For all diseases) | Participant/Subject History and Family History | General Health History |
|
Demographics
| The epilepsy-specific Demographics CRF Module contains additional data elements relevant to epilepsy research, including: education, disability status, psychological testing history and language status. |
0.0
| 5/28/2010 | Epilepsy | Participant/Subject Characteristics | Demographics |
|
Classification of Seizures
| Based on the current International League Against Epilepsy (ILAE) guidelines, this CRF Module is recommended to classify seizures for all epilepsy studies. |
0.0
| 5/28/2010 | Epilepsy | Participant/Subject History and Family History | Disease History/Disease State |
|
Classification of Etiology
| Based on the current International League Against Epilepsy (ILAE) guidelines, this CRF Module is recommended to classify etiology for all epilepsy studies. |
0.0
| 5/28/2010 | Epilepsy | Participant/Subject History and Family History | Disease History/Disease State |
|
Syndromes by Age of Onset
| Based on the current International League Against Epilepsy (ILAE) guidelines, this CRF Module is recommended to classify syndromes for all epilepsy studies. |
0.0
| 5/28/2010 | Epilepsy | Participant/Subject History and Family History | Disease History/Disease State |
|
General Physical and Neurological Exam
| Designed as a supplement to the General Physical Exam, this CRF Module contains physical and neurological elements, recommended for all epilepsy studies. |
0.0
| 5/28/2010 | Epilepsy | Assessments and Examinations | Physical/Neurological Exam |
|
International Spinal Cord Injury Core Data Set Collection Form
| The purpose of the International Spinal Cord Injury (SCI) Core Data Set is to standardize the collection and reporting of a minimal amount of information necessary to evaluate and compare results of published studies. The minimal amount of information includes date of birth and injury, gender, the cause of spinal cord lesion, and the neurologic status. |
1.0
| 6/7/2006 | Spinal Cord Injury | International SCI Core Data Set | |
|
Coriell’s Epilepsy Data Elements
| The NINDS Human Genetics DNA and Cell Line Repository maintained by the Coriell Institute for Medical Research (Coriell) requires certain data elements be collected for the genetic samples that are banked for epilepsy. This CRF Module includes those elements and can be found on Coriell's Web site. |
0.0
| 5/28/2010 | Epilepsy | Assessments and Examinations | Laboratory Tests and Biospecimens/Biomarkers |
|
MRI
| This CRF Module provides the minimum requirements for MRI evaluation in epilepsy to evaluate cause(s) of seizures and to confirm or direct investigations of the seizure focus. |
0.0
| 5/28/2010 | Epilepsy | Assessments and Examinations | Imaging Diagnostics |
|
fMRI
| This CRF Module provides the minimum requirements for fMRI evaluation in epilepsy. |
0.0
| 5/28/2010 | Epilepsy | Assessments and Examinations | Imaging Diagnostics |
|
MRI for Registration of MEG
| This is an administrative CRF Module and provides the minimum sequences, requirements, and recommendations for co-registration of MEG/ MSI source data. |
0.0
| 5/28/2010 | Epilepsy | Assessments and Examinations | Imaging Diagnostics |
|
CDE Recommendations for Behavioral Function
| As summary of the Frontal Systems Behavior Scale, including a description, scoring, and justification for its use as a recommended instrument |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Behavioral Function |
|
CDE Recommendations for Cognitive Activity Limitations
| As summary of the Cog-FIM, including a description, scoring, and justification for its use as a recommended instrument |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Cognitive Activity Limitations |
|
CDE Recommendations for Global Outcome
| A spreadsheet of Global Outcome Measures (i.e., GOSE, MPAI-4, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Global Outcome |
|
CDE Recommendations for Health-economic Measures
| As summary of the EuroQoL, including a description, scoring, and justification for its use as a recommended instrument |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Health-economic Measures |
|
CDE Recommendations for Neuropsychological Impairment
| A spreadsheet of Neuropsychological Impairment Measures (i.e., RAVLT, TMT etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Neuropsychological Impairment |
|
CDE Recommendations for Patient Reported Outcomes
| A spreadsheet of Patient Reported Outcomes Measures (i.e., Neuro-QOL, PROMIS, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Patient Reported Outcomes |
|
CDE Recommendations for Perceived Generic and Disease-Specific Health-Related Quality of Life
| A spreadsheet of Health Related Quality of Life Measures (i.e., SWLS, QOLIBRI, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Perceived Generic and Disease-Specific Health-Related Quality of Life |
|
CDE Recommendations for Physical Function
| A spreadsheet of Physical Function Measures (i.e., FIM, NOS-TBI, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Physical Function |
|
CDE Recommendations for Post-concussive/TBI Symptoms
| A spreadsheet of Post-concussive/TBI Symptoms Measures (i.e., RPQ, NSI, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Post-concussive/TBI Symptoms |
|
CDE Recommendations for Psychological Status
| A spreadsheet of Psychological Status Measures (i.e., AUDIT, ASSIST, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Psychological Status |
|
CDE Recommendations for Recovery of Consciousness
| A summary of the JFK Coma Recovery Scale - Revised, including a description, scoring, and justification for its use as a recommended instrument |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Recovery of Consciousness |
|
CDE Recommendations for Social Role Participation
| A spreadsheet of Social Role Participation Measures (i.e., CHART-SF, RPQ, etc.) with a summary of their functionality and justification for their use as a recommended instrument. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Outcomes and End Points | Social Role Participation |
|
Definition of Traumatic Brain Injury
| This guideline serves to define Traumatic Brain Injury (TBI) and break down each element of the definition and provide symptoms/examples of each. |
1.0
| 4/1/2010 | Traumatic Brain Injury | Disease/Injury Related Events | History of Injury |
