HCR 562_Data Mgmt_M3 CRF Assignment_Part 2_Template-2

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Arizona State University *

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Dec 6, 2023

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HCR 562 Data Management Module 3: Assignment (Part 2) Complete the CRF for Screening 1. Date of Visit Template: use the script above to complete this section of the Template  COMPANY NAME INVESTIGATIVE PRODUCT NAME Center Number Patient Number Patient Initials CRF Page No. 1 ___ ___ ___ ___ ___ ___ ___ ___ ___ DATE OF VISIT: ____ - ____ - _____ YYYY MM DD SCREENING and BASELINE VISIT (1) NOTE: Kindly mark  in appropriate boxes . (ie click on the empty box and “Symbol” will open – you may then select  and it will load in place of the empty box) 1 Adam C. Blue (ACB) is a 58-year-old (born August 15, 1963) male interested in participating in ANUCHHI/XYA-LE/16-17/001, a study looking at a new treatment for tennis elbow. Subjects are required to come to the study site for a total of six (6) visits including today’s Screening visit. ACB has arrived at the clinic on December 1, 2021 at 8:00am. Your center number is 028. The patient’s number is 115.

2 Subject arrived at 8:00am, as noted earlier. Subject waits in the waiting area. 8:10am : Potential subject presenting with elbow pain is escorted to an exam room by the Study Coordinator (SC), Pamela Smith. The SC introduces herself to the subject, thanks him for his interest and explains that she will discuss the study with him. The SC explains that the study is six (6) months long from Screening to the last visit. She explains that the study is to compare the investigational product (IP) to a corticosteroid drug; to determine if the IP helps subjects with LE recover quicker and with less pain. She explains the various procedures and the risks associated with the procedures as well as risks with IP and corticosteroid. She tells the subject that his participation is voluntary and also reviews all participant rights. 8:25am : She provides ACB an informed consent document and a HIPAA document for his review, and mentions she is available to answer any questions. She mentions she will need to review the inclusion and exclusion criteria with him prior to starting the study or performing any study-related activities. She explains he can take as much time as he needs to review the documents and ask questions. She explains that if he elects to proceed, todays visit will include activities for the Screening Visit. If necessary, he may need a week to “wash out” or discontinue any NSAIDs he may be taking in which case he would need to return in (7+) days to complete Visit 1 activities: randomization, study drug

9:25am : ACB signs the consent document and the HIPAA document dated today, December 1, 2021, at 09:25AM local time. (Use this date to calculate any other dates required in the CRF). 9:30am : The subject hands the doctor a copy of documentation obtained from his Primary Care Physician (PCP) during his last preventative health visit. The visit with his PCP occurred 28 days ago, Nov 4, 2021. (NOTE: if you calculate days from 11-4-21 to 12-1-21 including 11-4, you will get 28 days). The documentation outlines his medication and physical health status. The PCP was the referring physician to this visit. 9:32am : Per the documentation which is consistent with subjects verbal report, ACB was taking Ibuprofen for Tennis Elbow (TE) pain up until today. His PCP prescribed Ibuprofen on Nov 4th. Of note, the report documents that the PCP diagnosed ACB with TE 3 months on Aug 30, 2021 by examination and ultrasound. At that time, they started treatment for his left elbow pain with Tylenol, later switching to Ibuprofen. ACB agrees to stop taking Ibuprofen for study participation as he understands this requirement from reviewing the consent. He also agrees to refrain from any concomitant medication that include NSAIDs (See Protocol Inclusion #8). Today is the recorded last use of NSAIDs. (NOTE: if you are unfamiliar with what drugs fall under the label “NSAID” you should stop and research this before proceeding – consider “NSAID List” or “Are Tylenol or Ibuprofen NSAIDs”). He started taking Ibuprofen for elbow pain at 600mg a day, again with the last dose today. He confirms that he has not been involved in any other clinical trials during the past 30 days. As confirmed in the PCP documentation and verbally, ACB has not received corticosteroid treatments in the past year. The SC confirms with ACB that while he can sign informed consent at today’s Screening visit, he will require a one week wash out period for the Ibuprofen he has been taking. 9:40am: SC asks a few demographic questions while also confirming consistency of ACBs answers with the documentation provided by the PCP. The goal was to ask any additional questions necessary to clarify potential inconsistencies. The subject responds: Subject was born in August 15, 1963, male and identifies himself as non- Hispanic African American. SC takes his measurements: height is 6 foot 2 inches tall and he is one hundred and ninety-five pounds. He reports he lost 50 pounds last year. Dominate Arm is right arm and affected elbow (pain) is occurring in his left arm. 9:50am: SC performs procedures consistent with vitals after the subject has been quietly sitting for 5 minutes. Vitals, medical and concomitant medication history, as well as height/weight/BMI must be completed prior to physician exam. SC calculates the participant’s BMI. (NOTE: the BMI is not listed here to give you practice 3

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calculating a BMI). SC reviews the protocol to verify she is consistent in her collection of data. She makes a few notes and prepares the physical exam papers for the PI to review. Template: use the script above and in previous sections to complete this section of the Template  2. Demographic Data Subject Initials: __ __ __ Gender: Male  Female  Age (in completed years) Ethnicity: Hispanic or Latino  Not Hispanic or Latino  Race: American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White      Height: __ __ __ . _ _ cm calculate feet and inches into cm w two decimal places Weight: __ __ __ ._ _ kg convert to kilograms from pounds with two decimal places BMI: __ __ ._ nhlbi.nih.gov to calculate Body Mass Index (BMI) with cm height and kg weight - with one decimal place. Dominant Arm : Right  Left  Affected Elbow: Right  Left  Reminder: No section of source (and associated CRFs) can be left blank without them generating queries and questions. Additional comments can be added with a signature and date if needed but blanks are not acceptable. Recorded by the SC after subject was resting for 5 minutes: Pulse (rpm): 67 Blood Pressure (mm of Hg): 148 / 89 Respiratory Rate (bpm): 13 Oral Body Temperature (°F): 98.5 Template: use the script above and in previous sections to complete this section of the Template  4

NOTE: Section 4 can be confusing if you apply standards for Normal/Abnormal results. Read carefully – studies do not all apply the same standards for vitals due to the unique criteria/backgrounds their study population present with. 3. Vital Signs Parameter Value N Normal or Abnormal. Must be one or the other AB If abnormal, specify one or the other NCS CS Pulse (rpm) *normal range here is 60-100 bpm __ __ rpm     B.P. (mm of Hg) *normal range here is less than 150 top # (SBP) And less than 90 bottom # (DBP) __ __ __ __ __     Respiratory Rate *normal range here is 12-16 bpm __ __ bpm     Oral Body Temperature ( ° F) *normal range here is 97.7-98.6 °F __ __. __ ° F     N= normal; AB = abnormal ( out of range of normal ); NCS = not clinically significant; CS = clinically significant 10:05am : Dr. Jones reviews the recorded vitals, the medical history details that are contained in the PCP referral notes. She then proceeds to ask a few clarifying questions about the subjects health, questions a few items in the medical history and then performes the necessary physical examination per protocol. She records the following data from the time with the subject : pain in left elbow started more than 3 months ago. The subject was first diagnosed with Tennis Elbow officially by his PCP on August 30, 2021 during a routine exam in the clinician’s office when subject presented with worsened symptoms. The subject’s last visit with his PCP occurred 28 days ago on November 4, 2021. Dates were found by the investigator in the PCP documentation that was brought to the visit by the subject. The PCP was the referring physician to the clinical trial. When questioned during the physical examination, ACB reported tenderness on palpation over the lateral epicondyle of humerus (See Protocol Inclusion #4)., VAS pain score > 45 (Protocol Inclusion# 5), diffuse pain with quick movement of elbow joint (Protocol Inclusion #6), lateral elbow pain that is maximal over the lateral epicondyle and increase with pressure on the lateral epicondyle and resisted dorsiflexion and/or middle finger (Protocol Inclusion #7). There is no evidence of external injury on ACB’s left elbow and ACB denies any known injury. 5

The subject reports being a previous smoker of 1 pack/day, but stopped in 2015. He notes recreational drinking and when probed further, subject noted occasional beer for a special sporting event like the Super Bowl or World Series but otherwise doesn’t drink. His medical history indicates no history of mental illness and no recreational drug use. While this information is self-disclosed, Dr. Jones sees no physical symptoms to the contrary that would prompt further investigation or diagnostic interventions. No abnormalities are noted by the PI during the physical exam. PI also reviews the vital signs collected by the SC (above). Template: use the script above and in previous sections to complete this section of the Template 4. Clinical Examination Parameter NAD If abnormal, specify *An abnormality would be any measure out of range for any of these body systems recorded in this source as well as those noted in the script. Respiratory System:  Cardiovascular System:  Parasympathetic nervous system:  Central Nervous System:  NAD = No Abnormality Detected No Urine pregnancy test is performed since subject is male and was born male. Note: In a real world situation you would check protocol for information on whether this is required. When its applicable only to females, then males would be “not applicable” as apposed to “no”/not done. Reason for this is that “no” is reserved for procedures that were required by protocol but not performed. “Not applicable” on the other hand, are showing compliance with the protocol. The protocol for this study tells us that we need to record “NA” for our male subject. Template: use the script above and in previous sections to complete this section of the Template  5.Urinary Pregnancy Test: Not Applicable  6

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Yes If yes, date and result No In no, reason Was urinary pregnancy test performed?  ____ ____ ______ YYYY MM DD  _____________ _ _____________ _ _____________ _ _____________ _ Result: Positive  Negative  10:45am : After the physical exam and after a short break at the request of the subject, SC takes the subject for Ultrasonography exam. Ultrasonography performed at the clinic on the affected elbow on December 1, 2021, and the result was positive doppler activity in left (affected) elbow. This was reviewed by the PI, signed and dated by the investigator as meeting inclusion criteria. A signed copy is placed in the subject’s source file. This detail is explained to the subject by the PI so as to keep the subject informed on the findings and its relation to the study. Template: use the script above and in previous sections to complete this section of the Template  NOTE: Students often miss points here by not recording the result here in sufficient detail. Plan to include whether the test result was positive or negative and for what body region . For instance positive might mean that a cyst or other abnormality was noted. But we were looking for lateral epicondylitis. So if you only write “positive” your data will not be interpreted correctly. Likewise, if you only write “left arm” but the finding was in the area just above or below the elbow, your data will not be interpreted correctly. You might want to add “left arm, affected elbow” to clarify the exact location. You need to specify “positive (for what) and add “exact location” I’ve given you the answer for this section but again this is a learning exercise not designed to trick anyone 6.Ultrasonography (US): Yes If yes, date and result No If no, specify Was Ultrasonography done?  _____ ___ ______ YYYY MM DD  _____________ _ 7

_____________ _ _____________ _ _____________ _ Result in brief: _____________________________________ _____________________________________ _____________________________________ _____________________________________ 11:20am: The subject is escorted back to a waiting area where he reads and relaxes while the SC asks for some time to review the protocol and her notes to verify she has all the necessary information to progress further in the visit. She records the medication from all sources and files and notes she has to date. Additional items noted during the visit:  He’s taken regular strength OTC (over the counter) Prilosec for GERD for 3 years per his PCP and continues taking it today. He takes it as prescribed on the package. He takes 20mg/once per day of Lisinopril * as medication for high blood pressure and has for 12 years. Starting in Dec of 2020 he began taking a 1000 u Vitamin D once a day because his doctor told him that his was low on Vitamin D. He’s been taking (2) OTC extra strength Tylenol for pain off and on for his elbow pain since it started but hasn’t taken any since the doctor started him on Ibuprofen – the day of his office visit with the PCP was the day he stopped taking Tylenol. *note to find a generic medication name, go to www.drugs.com or webmd.com to find the generic name for this drug. See also the following link that explains what generic / International Nonproprietary Names are for drugs. They help identify the international identification of the nonactive ingredient that is not priory owned by a company. https://www.drugs.com/inn.html . For example, cheeseburger verus McCheeseburger. Template: use the script above and in previous sections to complete this section of the Template  . The first drug is documented/formatted for you: Ibuprofen NOTE: Students typically lose the most points in Section 8 – be sure to double check your work carefully:  Generic (not brand) names should be used. Ex: Use Acetaminophen (not Tylenol)  Drug names should be capitalized  Dose or frequency is often incorrect  Dates are not complete – if you don’t know the month or day, use UNK. Ex: 2021/Unk/Unk 7. Medication History No. Generic Name Strength Dose Describe how many are taken at a time such as “2” 500 Tylenol Route 1=IV 2=IM 3=Oral 4=Other (specify ) Frequency 1= Daily or Q24HR 2=BD 3=TID 4=QID 5=Other (specify) Start Date (yyyy/mm/dd ) End Date (yyyy/mm/dd ) -leave blank if ongoing Mark X if ongoin g Indication 8

1 Ibuprofen 600mg 2 3 2 2021/11/03 2021/12/01 Left elbow pain 2 3 4 5 11:30am: SC now reviews all notes, source file, and medical history then completes the below chart. The PI reviews and completes the chart. In addition to the above : The PI confirms there is no pain in hand or shoulder/neck in the same arm with LE. PI confirms no history of trauma, ligament damage, fracture, tumor, or surgery of the elbow joint. PI confirms no clinical suspicion of insertion disorders, no complex regional pain syndrome, no history of cervical neuropathy or other nerve pathology, and no history of rheumatoid arthritis, peripheral vascular disease, sarcoidosis, metabolic disease such as gout, frozen shoulder, inflammatory arthropathy, chronic dislocation, spondyloarthropathy avascular necrosis, metabolic bone disorders or evidence of intra articular arthritis, connective tissue disease, clinically significant medical or psychiatric disease, or history of alcohol or recreational drug abuse within (5) five months prior to study randomization. As previously noted, subject agrees to discontinue Ibuprofen use starting today. Per the protocol, all NSAID use must be discontinued for one week prior to randomization and study drug administration (completed at Visit 1). Subject is now fully consented. All Screening activities are complete with the exception of No. 2 Inclusion/Exclusion Criteria. No. 8 Inclusion criteria related to NSAID wash out periods will be confirmed and documented when subject returns for Visit 1 in approximately days. A copy of the signed consent is provided to the subject. A return appointment is scheduled for December 10, 2021 to confirm subject meets all Inclusion/Exclusion criteria (first) then complete all Visit 1 study activities per the Schedule of Events (second). “NO NEED TO ADD SIGNATURES OR DATES – THIS IS A SIMULATION” ______________________________________________ ______________ Participant Signature Date ______________________________________________ ______________ Study Coordinator Signature Date 9

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HCR 562_Data Mgmt_M3 CRF Assignment_Part 2_Template-2

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