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HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page Adverse Event Tracking Log of Check box if there were no adverse events to be recorded  Date of PI Initials PI Initials Drug/Device Attribution5^ Action Taken4 Study Attribution5 Expected (Y or N) AE Treatment3 End Date Serious (Y or N) Start Date Severity/ Grade2 Adverse Event Description Outcome1 Adverse Event** (Select from Safety Profiler) Ongoing (Y or N) # Date Reported Insert question to ask participant (e.g Were there any adverse events? Y/N) # - AE number “1” indicates the first adverse event documented on the form, = the second, etc If the adverse event changes in severity, enter it as a separate adverse event row on the paper form using the same AE number as the one that ended **look up corresponding AE at: https://safetyprofiler-ctep.nci.nih.gov/ Outcome1 – Fatal – Not recovered/not resolved – Recovered w/sequelae – Recovered w/o sequelae – Recovering/Resolving Form Number Severity/Grade2 – Mild – Moderate – Severe – Life Threatening – Death (Fatal) AE Treatment3 – None – Medication(s) – Non-medication TX Version Date: 10/31/2019 Action Taken4 with Study Intervention – None – Interrupted – Discontinued – Dose reduced – Dose increased – Not Applicable Attribution/ Relatedness5 – Definite – Probable – Possible – Unlikely – Unrelated ^5 – Not Applicable (did not receive intervention) Commented [Notes1]: •Record only one diagnosis, sign or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as separate entries) •Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom •Death should not be recorded as an event but should be recorded as the outcome of the event The condition that resulted in the death should be recorded Adverse Event Tracking Log - Instructions Use the following instructions and definitions to guide you when entering information about adverse events (AE) and serious adverse events (SAEs) Update the form as needed to be study specific Please refer to your protocol and the applicable regulations (e.g GCP, FDA regulations, IRB guidelines) for additional information on adverse event tracking and reporting requirements # - A sequential number for each adverse event Changes in severity of an event are documented by adding a separate event to the log but retaining the same AE number in the # column Adverse Event Description – A brief description of the event Adverse Event – A short term used to help categorize AEs using the Common Terminology Criteria for AEs (CTCAE v5.0) Go to the Safety Profiler website (https://safetyprofiler-ctep.nci.nih.gov/) and enter your AE in the search bar The term listed under ‘Adverse Event’ should be entered in your log (Click on the AE term to see more information to help determine which Grade best fits the event.) Severity/Grade – Identify the severity/grade of the adverse event as defined by the protocol A scale is provided in the tracking log footnote* Severity/grade may be associated with impact on daily living and/or the required treatment required to resolve the adverse event Date Reported – The date the event was reported to the study team Start Date – The date the event began as reported by the participant or listed in the medical records End Date – The date the event resolved/recovered as reported by the participant or listed in the medical records If the event has not resolved/recovered at the end of study participation this field should be left blank Ongoing – If an event has not resolved/recovered this field should indicate ‘Yes’, the event is Ongoing Outcome – Identify the outcome of the adverse event by entering the corresponding value provided in the tracking log footnote* Serious – Select ‘Yes’ if the occurrence of the event suggests that the research places the participants or others at greater risk of harm than was previously known or recognized SAE Classification – If the event was determined to ‘Serious’ enter the corresponding value for SAE classification provided in the tracking log footnote The provided classification is based on the FDA’s definition of serious at 21 CFR 312.32(a) Additional guidance on SAE reporting for drug studies is available here Treatment – Identify any treatment provided for the adverse event by entering the corresponding value provided in the tracking log footnote* Intervention – The list of study interventions requiring adverse event tracking For drug/device studies, the name of each drug/device should be pre-populated in the form Non-drug/device adverse events should be categorized together under a separate column (e.g., “study”) or listed separately (e.g., “lumbar puncture”, “MRI”) depending on the study activities involved and study specific requirements for adverse event tracking Expected – Select ‘No’ if the event experienced by the participant is not consistent with the risk information described in any study related documents or published literature as it relates to the nature, severity, specificity, or frequency of the event when considering the characteristics of the participant population on study A separate determination should be made for each intervention See the OHRP definition of unexpected adverse and IRB guidance on adverse events for more information Attribution/Relatedness – Indicate the attribution/relatedness of the adverse event to each intervention by entering the corresponding value provided in the tracking log footnote* A separate determination should be made for each intervention Action Taken – Indicate what, if any, changes were made to the study intervention as a result of the adverse event by entering the corresponding value provided in the tracking log footnote* * - Except for the SAE classifications, the tracking log footnotes are provided as examples and should be updated to be study/protocol specific as needed Instructions Version Date: 10/22/2019 HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page of Check box if there were no adverse events to be recorded  Adverse Event Tracking Log Date of PI Initials PI Initials Action Taken6 Attribution5^ Expected (Y/N) Intervention Treatment4 SAE Classification3 Serious (Y/N) Outcome2 Ongoing (Y/N) End Date Start Date Adverse Event (Select from Safety Profiler) Date Reported # Adverse Event Description Severity/Grade1 Insert question to ask participant (e.g Were there any adverse events? Y/N) Drug Drug Drug Study Drug Drug Drug Study Drug Drug Drug Study Drug Drug Drug Study Drug Drug Drug Study Drug Drug Drug Study Severity/Grade1 – Mild – Moderate – Severe – Life Threatening – Death (Fatal) Form Number Outcome2 – Fatal – Not recovered/not resolved – Recovered w/sequelae – Recovered w/o sequelae – Recovering/Resolving SAE Classification3 – Fatal – A life-threatening occurrence – Requires inpatient hospitalization or prolongation of existing hospitalization – Results in persistent or significant disability or incapacity – A congenital anomaly/birth defect – A significant medical incident that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above Version Date: 10/22/2019 Treatment4 – None – Medication(s) – Non-medication TX Attribution/ Relatedness5 – Definite – Probable – Possible – Unlikely – Unrelated ^5 – Not Applicable Action Taken6 with Study Intervention – None – Interrupted – Discontinued – Dose reduced – Dose increased – Not Applicable HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page of Commented [Notes1]: General prompt question - If no concurrent medications, none will be entered on the log form Verification that all other fields were deliberately left blank Insert question to ask participant: Are you currently taking any medications (prescription, over the counter, vitamins, minerals, supplements), or non-drug therapy? Concomitant Medication Log # Medication/ Non-drug Therapy Indication Dose (per admin) Dose Units1 Schedule/ Frequency2 Dose Form3 Route of Administration4 Start Date End Date Baseline Med (Y/N) Continuing at end of study (Y/N) Commented [Notes2]: Record sequential numbers for each Medication/non-drug therapy, beginning with “1” Number sequence for all following pages should continue and should NOT be restarted to allow a unique number per medication/nondrug therapy Commented [Notes3]: Record only one medication per line If a medication is used for multiple indications, list the medication again with each indication as a new line or entry Commented [Notes4]: Users have the option of selecting Dose of medication per Administration or Total Daily Dose Commented [Notes5]: If the subject has been taking the medication for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date In the event that the DAY is unknown, it is recommended to enter 01 (e.g 05-01-1965) In the event that both the day and month are unknown, enter 01 for both fields (e.g 01-01-1965) A best estimate should be used to capture the year • Medications taken during the study are expected to have a complete start date •Prior medications that are exclusionary should have both a start and end date Dose Units1 - g (gram) - mg (milligram) - µg (microgram) - L (liter) - mL (milliliter) - IU (International Unit) - Other Form Number Schedule (frequency)2 - QD (once a day) - QOM (every other mo) - BID (twice a day) - QH (every hour) - TID (three times a day) - AC (before meals) - QID (four times a day) 10 - PC (after meals) - QOD (every other day) 11 - PRN (as needed) - QM (every month) 12 - Other Version Date: 10/28/2019 Dose Form3 - Tablet - Gas - Capsule 10 - Gel - Ointment 11 - Cream - Suppository 12 - Powder - Aerosol 13 - Implant - Spray 14 - Chewable - Suspension 15 - Liquid - Patch 99 - Other Route of Administration4 - Oral - Inhalation - Topical - Intravenous - Subcutaneous 10 - Intraperitoneal - Intradermal 11 - Nasal - Transdermal 12 - Vaginal - Intraocular 13 - Rectal - Intramuscular 14 - Other HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Demographics Subject UWHC Medical Record Number*: First Name*: Middle Name (or initial): Last Name*: / Birthdate*: Month / Day Year Gender*: (check one) Ethnicity*: (check one) Male Female Unknown or Not Reported Hispanic Non-Hispanic Unknown or Not Reported Race*: (check all that apply) American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White or Caucasian Unknown or Not Reported Other Medical Record Number(s): Medical Record Number Hospital/Care Provider (e.g VA Hospital, Meriter Hospital, EPIC) Contact Information: Address: City: Phone Number: Home Work Cell Other Preferred method of contact: State: Alternate Phone Number: Home Cell Unit #: Zip: Email address: Work Other Emergency Contact: Name: Address: City: Phone Number: Home Work Cell Other Preferred method of contact: State: Alternate Phone Number: Home Cell Unit #: Zip: Email address: Work Other *indicates required field Form Completed By: Form Number Date: Version Date: 10/28/2019 Year HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page of # Start Date Category End Date Description (see below) Impact Subject Safety* Affect Data Integrity* Affect Subject’s Willingness to Participate?* Yes Yes Yes No No No Not Applicable Not Applicable Not Applicable Yes Yes Yes No No No Not Applicable Not Applicable Not Applicable Yes Yes Yes No No No Not Applicable Not Applicable Not Applicable Yes Yes Yes No No No Not Applicable Not Applicable Not Applicable Yes Yes Yes No No No Not Applicable Not Applicable Not Applicable Reported to IRB Date of PI Initials Does the deviation/UP have the potential to: PI Initials Subject Deviation/Unanticipated Problem Tracking Log / / Not Applicable / / Not Applicable / / Not Applicable / / Not Applicable / / Not Applicable *If one or more is answered yes for any event, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event) Please refer to the HSIRB Reportable Event guidance for additional information (https://kb.wisc.edu/hsirbs/18324) Category: Consent Deviation Drug/Device Administration/Accountability Enrollment Deviation Procedural Deviation Loss of Confidentiality Other (describe) Form Number Version Date: 10/29/2019 Commented [JR1]: OnCore Entry Instructions: The Subject Deviation/UP form is not a separate eCRF in OnCore, but rather a standard part of the OnCore > Subject Console To enter the data, click the ‘Deviations’ menu item on the left side menu bar within the Subject Console Click ‘New’ and enter data obtained on the paper version of the form Refer to https://kb.wisc.edu/ictr/page.php?id=64625 for the full instructions (requires NetID to access) PI NAME, Protocol or IRB Number, Protocol Short Title Page of Device Accountability Log Form Number: Version Date: 10/28/2019 RET=Returned DES=Destroyed REP=Repaired Reason Confirmed by (staff initials) Device Disposition Date of final Device Disposition Device Return/Repair/Destruction Dispensed by (staff initials) Subject Study ID Date Used Device Use Received by (staff initials) Lot #, Serial #, or Model Number(s) Batch # or Device Type Date Received Device Receipt Comments Form Number: *Calculation of % Compliance = Actual taken / Estimated to be taken Version Date: 10/28/2019 % compliance* Page Actual number of units used/taken Returned by Subject Expected number of units to be used/taken Verified by (staff initials) Date Returned Number of units returned Dispensed to Subject Number of Containers Returned Dispensed by (staff initials) Date Dispensed Number of Units Dispensed Number of Containers Dispensed Unit Dose (e.g mg) Lot Number(s) Subject Study ID Subject Initials PI NAME, Protocol or IRB Number, Protocol Short Title of Drug Dispensation & Accountability Log Compliance Form Number *Calculation of % Compliance = Actual taken / Estimated to be taken Version Date: 10/28/2019 Page % compliance* Returned by Subject Estimated number of units to be used/taken Subject ID Actual number of units used/taken Verified by (staff initials) Date Returned Number of units returned Dispensed to Subject Number of Containers Returned Expected Date of First Dose Dispensed by (staff initials) Date Dispensed Subject Initials Number of Units Dispensed Number of Containers Dispensed Randomization Number Lot Number(s) HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title of Drug Dispensation & Accountability Log Compliance Commented [CDASH Std1]: Optional Investigator Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: INVID HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Commented [CDASH Std2]: Highly Recommended Protocol/Study Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: STUDYID Year Eligibility Criteria Inclusion Criteria Patients who meet all of the following criteria are eligible for enrollment as study participants: Yes No Exclusion Criteria Patients who meet any of these criteria are not eligible for enrollment as study participants: Yes No 10 11 12 Form Completed by: Date: Site PI Signature: Date: OnCore Entry Instructions: The Inclusion/Exclusion Checklist is not a separate eCRF in OnCore, but rather a standard set of data entered for every subject as part of the Subject Console To enter the Inclusion/Exclusion data, click the ‘Eligibility’ menu item on the left side menu bar within the Subject Console Click ‘Update’ and enter data obtained on the paper version of the form Form Number Version Date: 10/20/2016 Page of Commented [CDASH Std3]: Highly Recommended Subject Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: SUBJID HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Year Commented [JR1]: OnCore Entry Instructions: The Inclusion/Exclusion Checklist is not a separate eCRF in OnCore, but rather a standard set of data entered for every subject as part of the Subject Console To enter the Inclusion/Exclusion data, click the ‘Eligibility’ menu item on the left side menu bar within the Subject Console Click ‘Update’ and enter data obtained on the paper version of the form Eligibility Criteria Inclusion Criteria Patients who meet all of the following criteria are eligible for enrollment as study participants: Yes No Exclusion Criteria Patients who meet any of these criteria are not eligible for enrollment as study participants: Yes 10 11 12 Form Completed by: Date: Site PI Signature: Date: Form Number Version Date: 10/28/2019 Page of No HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID Informed Consent/HIPAA Authorization Obtained / Date Signed: / Time: Document(s) signed : Consent Refused (using 24 hour format) Version Date Approval Date Commented [JR1]: OnCore Entry Instructions: The Informed Consent form is not a separate eCRF in OnCore, but rather a set of standard data collected for every subject in OnCore, each time Informed Consent is obtained To enter the Informed Consent data, click the ‘Consent’ menu item on the left side menu bar within the Subject Console Click ‘Update’ and ‘Add’ to and enter data obtained on the paper version of the form Commented [Notes2]: Time needed to confirm that informed consent was obtained prior to performing study procedures Commented [Notes3]: Time of day format based on International Organization for Standardization (ISO 8601:2004) Time of the day is the time representation, using the 24-hour timekeeping system It is hh:mm:ss where hh is the number of complete hours that have passed since midnight, mm is the number of complete minutes since the start of the hour, and ss is the number of complete seconds since the start of the minute Consent Form, and related study documents, was thoroughly reviewed with the subject Yes No Subject had sufficient time to review the documents and ask questions Yes No Informed consent/HIPAA Authorization obtained prior to any study related procedures Yes No A copy of the signed documents have been given to the subject Yes No Name of person that obtained consent: Comments: Informed Consent Refused Time: : Not Applicable (using 24 hour format) (e.g hh:mm) Comments: This form should be completed for each Informed Consent process (i.e if Re-consented) Form Number Version Date: 10/28/2019 Page of HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Year Medical History (General) Diagnosed condition? Body System Diagnosis/Condition/Surgery Onset Date Or Year Current Problem [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No [insert body system being inquired about] Yes No Yes No Other (specify) Yes No Yes No Medical History Not Obtained ADDITIONAL NOTES: MEDICAL HISTORY OBTAINED BY: Form Number: Version Date: 10/28/2019 Page of Commented [Notes1]: It is highly recommended to have a disease specific medical history form with y/n questions relating to the disease/condition under investigation or to catch any of the specific inclusion/exclusion criteria Commented [Notes2]: Used to designate a particular category (e.g., “cardiovascular”) Commented [Notes3]: Please indicate if (e.g high blood pressure, appendectomy) has occurred /is occurring by checking “Yes” or “No” HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Note To File Applicability: Include subject ID(s) if NTF pertains to a particular subject or subjects RE: Written by: Date: / / Explanation of Event/Issue: Description of the issue/process/problem being documented, including (if applicable) how, when, and by whom the issue was identified, cause of issue (if known), corrective and preventive actions taken (when and by whom) Description of related forms/documents (if applicable): Author’s Signature Date PI’s Signature Date Note to File Guidance: Notes to the Study File are written to acknowledge a discrepancy or problem with the study’s conduct, or for other administrative purposes (such as to document where study materials are stored) Notes to the Study File should be written by the individual responsible for its content, and the author should sign and date the note If the Note to Study File pertains to an item for which the PI is responsible (subject protection, data integrity, etc.), the PI should co-sign and date the note to acknowledge his/her awareness of the issue Notes to the Study File should be kept on file in the study records and made available to study monitors or auditors reviewing the site’s documents and procedures Form Number Version Date: 10/30/2019 HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Exam Date: Month / Day Year Physical Examination Time: : Physical Examination not performed (using 24 hour format) (e.g hh:mm) Visit Number (check one): Visit # Visit # Body System [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] [insert body system to be examined] Other (specify in Comments) Visit # Visit # Visit # Visit # Finding* Comments (check one) (*required if Abnormal) Clinically Significant* (Y/N) Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Normal Abnormal* Not examined Additional Notes: Physical Examination performed by: Principal Investigator Signature: Form Number Version Date: 10/28/2019 Date: Page of Subject ID: HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Page: of Research Sample Inventory/Tracking Storage Location (including building and room number): Freezer number: Subject Initials Subject ID # Shelf Number: Visit Number Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit Visit - Form Number Version Date: 10/28/2019 Date/Time sample put in freezer / MM / : AM PM / DD AM PM YYYY AM PM / YYYY YYYY : / DD / DD MM AM PM / AM PM / YYYY YYYY : / DD / DD MM AM PM : AM PM / YYYY YYYY : / DD : MM AM PM / DD / YYYY : / : / DD MM MM AM PM / MM Date/Time sample removed from freezer / YYYY : MM Cell # / DD MM Box # Rack Number: MM / DD : YYYY AM PM Sample Outcome Shipped Analyzed Lost Other: Shipped Analyzed Lost Other: Shipped Analyzed Lost Other: Shipped Analyzed Lost Other: Shipped Analyzed Lost Other: Commented [Notes1]: To be updated per protocol Serious Adverse Event (SAE) Tracking Log Principal Investigator: IRB Number: _ OnCore Protocol Number: Page of Commented [JR1]: Instructions for entry into ICTR OnCore: https://kb.wisc.edu/ictr/page.php?id=21220 Outcome Event Event Start Date End Date Attribution Adverse Event* (Select from Safety Profiler) Unexpected (Y or N) SAE Description Date Site Became Aware of Event (Reported Date) Grade Subject ID No SAE Classification Short Protocol Title: _ *look up corresponding AE at: https://safetyprofiler-ctep.nci.nih.gov/ SAE Classification Grade Attribution Outcome - Fatal (resulted in death) - A life-threatening occurrence - Requires inpatient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability/incapacity - Results in congenital anomaly/birth defect - A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above - Mild - Moderate - Severe - Life Threatening – Death (Fatal) – Definite – Probable – Possible – Unlikely – Unrelated – Fatal – Not recovered/not resolved – Recovered w/sequelae – Recovered w/o sequelae – Recovering/Resolving Form Number Version Date: 10/31/2019 Serious Adverse Event (SAE) Tracking Log Principal Investigator: IRB Number: OnCore Protocol Number: Subject ID# Page of Commented [JR1]: Instructions for entry into ICTR OnCore: https://kb.wisc.edu/ictr/page.php?id=21220 Outcome Event Event Start Date End Date Attribution Adverse Event* (Select from Safety Profiler) Unexpected (Y or N) SAE Description Date Site Became Aware of Event (Reported Date) Grade SAE Number SAE Classification Short Protocol Title: _ *look up corresponding AE at: https://safetyprofiler-ctep.nci.nih.gov/ SAE Classification Grade Attribution Outcome - Fatal (resulted in death) - A life-threatening occurrence - Requires inpatient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability/incapacity - Results in congenital anomaly/birth defect - A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above - Mild - Moderate - Severe - Life Threatening – Death (Fatal) – Definite – Probable – Possible – Unlikely – Unrelated – Fatal – Not recovered/not resolved – Recovered w/sequelae – Recovered w/o sequelae – Recovering/Resolving Form Number Version Date: 10/31/2019 HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Year Commented [JR1]: OnCore Entry Instructions: The Off Study form is not a separate eCRF in OnCore, but rather a standard form for every subject part of the Subject Console To enter the off study data, click ‘Follow-up’ menu item on the left side menu bar within the Subject Console Enter the Off Study Date field Select the appropriate Off Stud Reason If the subject withdrew early, select ‘Subject Withdrawn’ from the Off Study Reason drop down box with the corresponding indicator of PRIOR to or AFTER enrollment, and enter the specific reasons in the Explain field Subject Off Study / Date subject went Off Study: Month / Day Year Last Visit Completed: Visit # Visit # Visit # Visit # Visit # Visit # Visit # Visit # Commented [Notes2]: To be modified per protocol INDICATE OFF STUDY REASON: (select only one) Study Activities Completed If the subject was withdrawn prior to completing the study (i.e early withdrawal), select one of the following: Subject withdrawn – by Subject PRIOR to enrollment** Subject withdrawn – by Subject AFTER enrollment** Subject withdrawn – by PI PRIOR to enrollment** Subject withdrawn – by PI AFTER enrollment** Death Other** If the subject was withdrawn, indicate specific reason(s): (select all that apply) Subject lost to follow-up Subject refused follow-up Due to adverse events or complications Other** Commented [JR3]: OnCore Entry Instructions: Enter as text into the Subject Console > Follow-up > Subject Off Study Update > Explain field) **Additional explanation required: Commented [JR4]: OnCore Entry Instructions: Enter into the Subject Console > Follow-up > Subject Off Study Update > Explain field FORM COMPLETED BY: Form Number Version Date: 10/30/201p Page of HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Date: Month / Day Year Telephone Contact Telephone contact not performed If Telephone contact not performed, complete the Subject Deviation form Date of Contact Attempt Month Day Year (MO) (DD) (YYYY) Time Contact Occurred Contact Attempt #1 No answer Left Voice message Left Message w/ Line Busy Other: No answer Left Voice message Left Message w/ Line Busy Other: No answer Left Voice message Left Message w/ Line Busy Other: No answer Left Voice message Left Message w/ Line Busy Other: 2 AM PM Yes No AM PM Yes No AM PM Yes No AM PM Yes No Contact Attempt #2 Contact Attempt #3 Contact Attempt #4 / Date telephone contact completed: Month Form Number Outcome Version Date: 10/30/2019 Page of / Day Year HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Telephone Contact (continued) [INSERT TEXT AS REMINDERS TO RESEARCH STAFF] QUESTION(S) TO BE ASKED Since your last study contact, have you had any changes in health status, medical conditions, or adverse events? Concomitant Medications Log completed (if applicable)? Adverse Event Symptoms reviewed with Subject? Adverse Event Tracking Log Completed (same log form for all visits)? If any AE has ‘Yes’ in Serious column, complete SAE form and enter the information in Subject Console > SAEs screen of OnCore? Does the medical history form need to be updated? Were there any activities that deviated from the defined protocol? If yes, completed the Deviation/Violation form and enter the information in the Subject Console > Deviations screen of OnCore? Subject payment confirmed (if applicable) OTHER QUESTION TO ASK(if applicable) Form No COMMENTS: TELEPHONE CONTACT CONDUCTED BY: FORM COMPLETED BY: Form Number Version Date: 10/30/2019 DATE: Page of Yes No Yes Yes Yes No No No Yes No Yes Yes No No Yes No Yes Yes No No HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID / Exam Date: Month / Day Year Vital Sign Measurements (Standard) Vital Sign Measurements not performed Visit Number (check one): Visit # Visit # Visit # Height: Visit # Visit # Visit # inches Weight: Height not measured Time: : lbs Weight not measured (using 24 hour format of hh:mm) Temperature: Method: (check one) Fahrenheit Oral Axillary Temperature not measured Tympanic Respiratory Rate: breaths/min Respiratory Rate not measured Heart Rate: beats/min Heart Rate not measured Systolic Blood Pressure mmHg Diastolic Blood Pressure mmHg Method: (check one) Manual Automated Location: (check one) Left Arm Right Arm Position: (check one) Sitting Supine Blood Pressure not measured Standing Additional Notes: Vital Sign Measurements obtained by: Form Number Version Date: 10/30/2019 Page of