CDE Detailed Report

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether related or not related to the study intervention or procedure. Each AE should be listed on a separate row. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE (UAE). An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. Code the adverse event verbatim text with the Common Terminology Criteria for Adverse Events (CTCAE) low level term name. CTCAE is a freely available standard terminology for adverse event data.

NeuroRehab Supplemental - Highly Recommended for motor rehabilitation studies.

No instructions available

Choose all that the participant/ subject receives. Response is obtained from report by the participant/subject, a reliable proxy or medical records. Add date stamp for when assessed. Recommend collection at end of initial medical care.

NeuroRehab Supplemental - Highly Recommended for studies where sleep may be relevant to the outcome.

No instructions available

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

NeuroRehab Supplemental - Highly Recommended for studies where pain may be relevant to the outcome. Can be more than one, so check all that apply.

NeuroRehab Specific: Refers to the neurological disorder being studied. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

NeuroRehab Supplemental - Highly Recommended for studies where pain may be relevant to the outcome. Can be more than one, so check all that apply.

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Choose one. Record the investigator's assessment as to whether there is at least a reasonable possibility that the AE is related to (or caused by) use of the study intervention. Definitions for each of the relatedness response should be supplied in the protocol.

Choose all that apply.

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether related or not related to the study intervention or procedure. Each AE should be listed on a separate row. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE (UAE). An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. See the Data Dictionary for additional information on coding the adverse events using either the Common Terminology Criteria for Adverse Events (CTCAE) or the Medical Dictionary for Regulatory Activities (MedDRA).

NeuroRehab Supplemental - Highly Recommended for studies where pain may be relevant to the outcome. On a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, how bad is your pain right now? 0 = no pain; 10 = the most intense pain imaginable Please note that if there is more than one pain, this section should be consistent with the International Spinal Cord Injury Pain Basic Data Set and apply to Worst, 2nd Worst and 3rd Worst pains.

Enter the name of the study site.