ࡱ>      GbjbjVV j<<=t t |||@`|,*x !d!4)))))))+F.`)$ $$))k)k)k)$j)k)$)k)k)k)`>]YA|E%Nk)))0,*k)/&/k)/k)P""k)[#l#""")))X""",*$$$$/"""""""""t ~:  SOURCE DOCUMENT INVESTIGATOR: ____________________ SITE NUMBER _____________ Subject Name: __________________________ Subject Initials: ______ Subject Number: ______________ Date of Birth: ____/_____/____ Sex:  FORMCHECKBOX Male  FORMCHECKBOX Female Race: _______ Ethnicity________ Education Level_____________ Current Employment Status___________________ Emergency Contact: Name ___________________ Relationship: ___________ Address ___________________________________________ ___________________________________________ Telephone _______________________ __________________ FOR INVESTIGATORS PATIENT FILE ONLY DO NOT FILE THESE DOCUMENTS IN THE PATIENTS MEDICAL RECORD BASELINE DATE OF VISIT: _____/_____/_____ Subject has been asked to participate in the ______ to assess _________________ ________________________________________________________________________________ The study has been discussed with the subject and all questions were answered  FORMCHECKBOX . Consent Form (version dated ____________) was signed on ____________________ at __________ (Time) prior to the performance of any study related procedures. (Any standard of care procedures performed or utilized to qualify the subject for enrollment should be clearly documented as such) The subject has been provided with a SIGNED copy of the signed Informed Consent  FORMCHECKBOX . Name of person obtaining consent ________________________________ REVIEW INCLUSION/EXCLUSION WORKSHEET Subject meets INCLUSION/EXCLUSION criteria?  FORMCHECKBOX Yes  FORMCHECKBOX NO If no, contact sponsor: *Date of Contact: _____/_____/_____ Name of Person Contacted: ____________________________ Exception Granted:  FORMCHECKBOX Yes  FORMCHECKBOX No Summary of contact Outcome: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ __________________________________ __________________ Signature Date MEDICAL HISTORY SOURCE OF THIS INFORMATION  FORMCHECKBOX  Patient interview  FORMCHECKBOX  Medical record  FORMCHECKBOX  Other ADAPT THIS FORM TO YOUR STUDY SPECIFIC NEEDS NormalAbnormDescribe abnormalityEENTPulmonary Dermatologic (rash, etc.)Gastrointestinal Tract DiseaseGenitourinaryMusculoskeletal NeurologicEndocrine & MetabolicNeoplastic DiseaseCardiovascularPsychiatric Other FEMALES: Post Menopausal  FORMCHECKBOX  Surgically incapable of childbearing  FORMCHECKBOX  (verified in medical record)  FORMCHECKBOX  YES  FORMCHECKBOX  NO Practicing an acceptable method of birth control  FORMCHECKBOX  Specify:________________________________ LMP: ___________________ Normal menstrual pattern x 3 months  FORMCHECKBOX  Yes  FORMCHECKBOX  No; Clarify____________________________________________  FORMCHECKBOX  Agrees to use an effective method of birth control throughout the study period if of childbearing potential SMOKING / ALCOHOL Has the patient ever smoked cigarettes? ____________ Number of year's patient smoked cigarettes__________ Average number of cigarettes smoked per day during that time_________ Does the patient drink alcoholic beverages? ________ CURRENT THERAPY / MEDICATIONS  FORMCHECKBOX  Record on Concomitant Therapy Log for medications Pharmacy profile  FORMCHECKBOX  YES  FORMCHECKBOX  NO __________________________________ __________________ Signature Date PHYSICAL EVALUATION INITIAL VITAL SIGNS, WEIGHT, HEIGHT Oral Temperature ___________ F Respiration Rate ___________/minute Pulse Rate _________/minute Weight ___________lb BMI_______(not over 40) Height _________in. Blood Pressure ______________MmHg IF PHYSICAL EXAM RESULTS ARE NOT RECORDED HERE, INDICATE LOCATION OF SOURCE DOCUMENT:  FORMCHECKBOX  Progress note in medical record  FORMCHECKBOX  Other ___________________________ NormalAbnormalNot ExaminedDescribe AbnormalityHead, Neck and ThyroidEars, Nose and ThroatEyesChest (including Breasts)LungsHeartLymph NodesAbdomenAnorectalGenitaliaSkinMusculoskeletalNeurologicOther: Mental Status Perform Mental Testing PHYSICAL EXAM PERFORMED BY:_____________________________________________(M.D., NP, P.A.) ____________________________ __________________ Signature Date STUDY PROCEDURES INSERT STUDY SPECIFIC PROCEDURES CLINICAL LABORATORY ___ Central labs drawn and sent ___ Local labs drawn and sent EXAMPLES ____________________Exam Completed By:_________________________________________________ Report of exam (source document) dated __________ can be found in: (Neurological) History Exam Worksheet Completed By: ______________________________________ (Worksheet serves as primary source document) Comments:      _________________________________ ____________________________ Signature Date RANDOMIZATION DATE OF VISIT: _____/___/_____ VITAL SIGNS Oral Temperature ___________ F Respiration Rate ___________/minute Weight___________lbs. Pulse Rate _________/minute Blood Pressure __________ / _____________mmHg REVIEW Inclusion/ Exclusion Criteria  FORMCHECKBOX  Have the results of the pre-randomization testing ___STUDY SPECIFICS___ been obtained and reviewed?  FORMCHECKBOX Yes  FORMCHECKBOX No Has the signed consent been faxed to __________ CSPCC? -  FORMCHECKBOX Yes  FORMCHECKBOX No Subject continues to meet admission criteria -  FORMCHECKBOX Yes  FORMCHECKBOX No* *If no, contact Sponsor Date of Contact: _____/_____/_____ Name of Person Contacted: _______________________ Exception Granted:  FORMCHECKBOX Yes  FORMCHECKBOX No Summary of contact Outcome: STRATIFICATION FACTORS: IF APPLICABLE RANDOMIZATION SUBJECT WAS RANDOMIZED TO:  FORMCHECKBOX _____________  FORMCHECKBOX  ____________ RANDOMIZATION NUMBER_______________________ DOSING OR STUDY INSTRUCTIONS REVIEWED WITH PATIENT  FORMCHECKBOX  MEDICATION DISPENSED and reviewed with patient: ___________________________________ ____________________________________________________________________________________ DIARY CARD COMPLETION REVIEWED  FORMCHECKBOX  DIARY CARD DISPENSED  FORMCHECKBOX  NEXT TELEPHONE CONTACT SCHEDULED FOR: ____________________ NEXT APPOINTMENT SCHEDULED FOR: ______________________(+or- ____ day window; extension requires Chairpersons approval) Additional comments:  FORMCHECKBOX  Progress note(s) concerning consent and randomization have been placed in patients medical record  FORMCHECKBOX  Patient medical record flagged to note study participation using: (for example)  FORMCHECKBOX  chart alert sticker __________________________________ __________________ Signature Date Study Visit # __ Use for visits/circle: DATE OF VISIT: _____/___/_____ VITAL SIGNS Oral Temperature ________ F Respiration Rate ___________/minute Pulse Rate___________/min. Weight ________lbs. Blood Pressure ____________mmHg STUDY PROCEDURES INSERT STUDY SPECIFIC PROCEDURES AS APPLICABLE ____________________________________________________________________________________________ ____________________________________________________________________________________________ CLINICAL LABORATORY  FORMCHECKBOX  Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  ________________  FORMCHECKBOX  ________________ DIARY CARD RETRIEVED  FORMCHECKBOX  REVIEWED WITH SUBJECT  FORMCHECKBOX  CONCOMITANT THERAPY Review and revise Concomitant Therapy Log for medications  FORMCHECKBOX  No Changes  FORMCHECKBOX  Changes HEALTH EDUCATION Assess Smoking status/changes: _______________________________________________ Assess exercise status/changes: ________________________________________________ INTERIM HEALTH CARE Since the last study visit, has the patient received any health care services?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes describe: ______________________________________________________________ _______________________________________________________________ ADVERSE EVENTS (Review previous entries on Adverse Events Tracking Log)  FORMCHECKBOX  New AEs or health changes noted on the Adverse Event Tracking Log and progress note  FORMCHECKBOX  No new AEs or health changes reported  FORMCHECKBOX  Previous AE(s) evaluated and current status recorded ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ STUDY MEDICATION Drug Dispensed: ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ Drug return: ________________________________________________________________ Compliance: ________________________________________________________________ DIARY CARD  FORMCHECKBOX  DISPENSED & INSTRUCTIONS REVIEWED Next appointment scheduled ______________________ (+or- day window; extension requires Sponsors approval) Comments:     __________________________________ __________________ Signature Date MISSED VISIT / EARLY WITHDRAWAL  FORMCHECKBOX  MISSED VISIT Reason: _____________________________________________________________________________________ _____________________________________________________________________________________ __________________________________________________________________________________________________________________________________________________________________________ Next appointment scheduled _________________________(+or- _____day window; extension requires sponsors approval)  FORMCHECKBOX  EARLY TERMINATION (COMPLETE __________ VISIT PROCEDURES) Reason: __________________________________________________________________________________________________________________________________________________________________________ __________________________________________________________________________________________________________________________________________________________________________  FORMCHECKBOX  DEATH Cause Of Death: _____________________________________________________________________________________ _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ADVERSE EVENT FOLLOW UP:  FORMCHECKBOX  N/A  FORMCHECKBOX  refer to AE Tracking Log (and SAE log if applicable) COMMENT: ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ __________________________________ __________________ Signature Date CONCOMITANT THERAPY LOG MEDICATIONS (Cumulative Document) Note: Check Pharmacy profile if one exists at your facility Prior and Concomitant TherapyStart DateCont.End DateRouteTotal Daily Dose or (PRNIndication(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN(yes(PRN ADVERSE EVENTS TRACKING LOG (Cumulative Document) Adverse EventStart DateSeverityRelationship to study DrugEnd DateOutcomeTherapy Given Specify(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown(None (Doubtful (Possible (Probable (Certain(Persisted (Resolved (Unknown Investigator signature:________________________________________________ Date:_________________ Inclusion/Exclusion Worksheet INSERT STUDY SPECIFIC CRITERIA Signature of Person Completing Form__________________________ Date____________ Investigator must affirm that patient meets study eligibility criteria     Protocol # Subject ID _______ Compliments of: SMART Site Monitoring, Auditing and Review Team VA Cooperative Studies Program Albuquerque, NM 4/14/05 Compliments of: SMART Site Monitoring, Auditing and Review Team VA Cooperative Studies Program Albuquerque, NM Compliments of: SMART Site Monitoring, Auditing and Review Team VA Cooperative Studies Program Albuquerque, NM  8RU      & / ? 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