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Samples, Forms, and WorksheetsContentsAdverse Event/Intercurrent Illness LogAdvertisement Sample—ApprovedBudgeting by Activity WorksheetBudgeting by Position WorksheetCase Report FormConcomitant MedicationsConfidentiality Letter or Nondisclosure AgreementContact Worksheet for Sponsor and VendorsContract or Clinical Trial AgreementCritique of an Inappropriate AdData Clarification or Query FormDelegation of Responsibility LogDrug Accountability or Dispensing LogDrug Study Announcement MemoFacilities LetterFDA Warning Letter Regarding Advertising ClaimsForm FDA 1572HIPAA Consent Template: Authorization Languagefor Research UseHIPAA Highlights for ResearchersIndemnification LanguageInformed Consent for IRB MembershipCompliments of Mountainside MD Press. From Conducting Clinical Research: A PracticalGuide for Physicians, Nurses, Study Coordinators, and Investigators, copyright Judy A. Stone,MD. For more information about the newly updated, revised and expanded second edition,please visit www.conductingclinicalresearch.com. You may reproduce any of these formsunder Creative Commons attribution, share alike licensing.1

Samples, Forms, and WorksheetsInformed Consent Form Requirements ChecklistInformed Consent Form TemplateIRB Communications ChecklistIRB Communications LogIRB Submission ChecklistOrientation for New Employees WorksheetPatent and Inventions ClausePatient InstructionsPatient Outcome LogPatient Problem ListPatient Wallet CardPregnancy and Contraceptive ClausesPreparing for an FDA Audit ChecklistPrestudy Activities WorksheetRegulatory Binder Contents ChecklistResearch Experience SummarySchedule of Activities WorksheetScreening and Enrollment LogSerious Adverse Event ReportSigns and Symptoms WorksheetSite Qualification SurveySite Qualification Visit AgendaSpecimen Collection and Preparation WorksheetSpecimen Shipping LogStudy Closeout ChecklistStudy Closure Report to the IRBStudy Feasibility ChecklistStudy Supply ChecklistTelephone LogUnderstanding HIPAA and Research HandoutCompliments of Mountainside MD Press and Conducting Clinical Research.2

Samples, Forms, and WorksheetsAdverse Event/Intercurrent Illness LogThe following sample illustrates the type of detail you need to capture if newsymptoms or problems arise among your study subjects. This log is not hardto keep, and this type of worksheet helps you not to miss the details that arerequired. It is much easier to do while you are evaluating the volunteer than tohave to go back to complete it later.Adverse Event/Intercurrent Illness LogDate ofProblem onset Severity*Nausea2/1/041InterventionrequiredWas the patientdropped from thestudy?Date ofresolutionCausality**2/4/042Phenergan 25mg tidNoNoNoDiarrhea2/1/0422/6/043Metronidazole125 mg qid x 10daysIV siteredness2/7/0412/8/041Warmcompresses** Rate causality (relation to study med):Not related0Possibly related1Probably related2Definitely related3* Rate severity of problem:None0Mild1Moderate 2Severe3Compliments of Mountainside MD Press and Conducting Clinical Research.3

Samples, Forms, and WorksheetsAdvertisement Sample—ApprovedThis brief advertisement passes muster—it is generic and not at all tempting. Anexample of an inappropriate ad is included in “Critique of an Inappropriate Ad”in this document.Do You Have a Condition?e.g., Pneumoniaor DiabetesA New Investigational Medicine Is BeingEvaluated in a Medical Research Study.Benefits include, at no cost:Study-related doctor visits, lab tests,study medication, and travel expensesFor info, call Dr. Investigator atCompliments of Mountainside MD Press and Conducting Clinical Research.4

Samples, Forms, and WorksheetsBudgeting by Activity WorksheetThis budget example, from an uncomplicated pneumonia study, is brokendown by activities required at each study visit for each patient. It includes timeestimates for key staff and lab tests specified by the protocol in the Scheduleof Activities. Unfortunately, the administrative times are estimates, based onprevious experience. Plan on everything taking twice as long as you initiallythought it would! This is more generous than some sponsors will agree to, butthere is wide variability. You can use this estimated allowance as a starting pointfor your planning and negotiations.Budgeting by Activity WorksheetProceduresPre-RxDuring RxIV to POEnd of RxTotalClinical and medical evaluationsObtaining informed consent 100 100History and physical 250 250Follow-up exams 75 75 75 225 100 100 100 600AdministrativePrincipal InvestigatorIRB, site-sponsor activities,adverse events reports, meetingtime, etc.* 300Study coordinator/research nurseInitial meeting time*Inservicing* 100 100 50 50Coordinator per-patient administrative activitiesScreening fee (estimating1 enrolled for 10 screened)Apache score calculation 200 200 50 50Adverse events recording 20 20 20 60Concomitant meds recording 10 10 10 30 15 15 15 70Patient diary review 25Compliments of Mountainside MD Press and Conducting Clinical Research.5

Samples, Forms, and WorksheetsProceduresPre-RxDispensing and accounting forstudy meds 50 50Patient instruction 25 25Scheduling of next visitDuring RxIV to POEnd of RxTotal 10 10 10 10 40 100 50 50 50 250Query resolution 50 50Monitoring visitsCRF data entry 100 100SAE forms 50 50IRB correspondence 50 50Sponsor/site correspondence 100 100Sponsor audit 100 100Lab tests/ProceduresHematology: cbc and differential 15 15 15 15 60 25 25 25 100Chemistry: chemistry panel 25Pregnancy test 20Urinalysis 15Specimen collection and handling 30Specimen shipping 30 20 30 30 15 30 30 120 30Microbiology 100 100 200Sputum cultureBlood cultures x 2 sets 60 60 120Sputum gram stain 20 20 40Sensitivities 75 75 150EKG 100 100 200CXR 200 200 400 25 100AncillaryPatient stipend fortime and travel 25 25Total (includes 20% overhead) 25 4120*Estimated fees based on anticipated number of subjects.Compliments of Mountainside MD Press and Conducting Clinical Research.6

Samples, Forms, and WorksheetsBudgeting by Position WorksheetIn budgeting by position, the time is estimated specifically for each staff member,for each patient visit. Note that this is an example, again from a pneumonia study,of the cost of care and feeding of the coordinator. It is an example only and maybear little resemblance to the realities at your site. This exercise would have tobe repeated for each member of the research team.Budgeting by Position WorksheetCoordinator PositionTime requiredper subject inminutesOccurrencesper studyvisitRecruitment301Screening201 18.00 18.001 180.00 180.00ActivityAdjustment for expected screen:enroll ratio (1 in 10)Cost peroccurrenceCost persubject 25.00 25.00Apache score calculation301 25.00 25.00Informed consent review601 50.00 50.00Inservice301 25.00 25.00Vital signs55 3.00 15.00Blood draw105 8.00 40.00Lab processing605 50.00 250.00Adverse events recording105 8.00 40.00Concomitant meds recording105 8.00 40.00Patient diary review205 16.00 80.00Dispensing and accountingfor study meds305 25.00 125.00Patient instruction305 25.00 125.0055 3.00 15.00CRF completion905 50.00 250.00CRF clarifications and monitor visits601 50.00 50.00CRF queries reconciliation155 25.00 125.00SAE forms601 50.00 50.00IRB correspondence303 50.00 150.00Sponsor/site correspondence155 25.00 125.00Sponsor audit601 25.00 25.00Scheduling of next visitTotal per patient680 1,828.00Compliments of Mountainside MD Press and Conducting Clinical Research.7

Samples, Forms, and WorksheetsCase Report FormThe following example shows the type of information you will need to capturein a CRF and a typical format for submission. The primary problems with CRFsare the volume of material required and the fact that each sponsor will collectthe information in a different format. Otherwise, you are simply transcribinginformation from your medical records or source documents when you fill outa CRF.WonderDrug Protocol 95-06Site Number: 126Subject Screening Number: 126-001Initials: ITDemographicsDate of birth (Day/Month/Year):Gender: C MaleRace:C FemaleC White C BlackC Hispanic/LatinoC AsianC OtherEligibilityDoes the subject meet all of the inclusion eligibility criteria? C Yes C NoIf no, specify the unmet inclusion criterion (by number):Does the subject meet any of the exclusion criteria? C Yes C NoIf yes, specify the met exclusion criterion (by number):If the subject does not meet all of the eligibility criteria, do not proceed with randomization.RandomizationWas the subject randomized? C Yes C NoIf not, why not? C Serious adverse eventC Withdrew consentC Screening lab test abnormalityC Other reasonEvaluation of Primary InfectionDate of enrollment:Duration of signs and symptoms prior to randomization (in days)Type of skin infectionC Decubitus ulcerC Diabetic footC Major abscessC Cellulitis (check only if complicated)C Postoperative wound infectionC Wound classification stage if a pressure ulcer:Compliments of Mountainside MD Press and Conducting Clinical Research.8

Samples, Forms, and WorksheetsLocation of primary site of infectionCode (refer to diagram for location codes): [diagram not included in this sample]Written description: [e.g., right buttock]Size of wound or ulcerLength: mmWidth: mm Depth: mmSize of erythema (redness) surrounding the woundLength: mmWidth: mmDrainageC NoneC BloodyC PurulentUnderlying predisposing risk factorsC Diabetes C Peripheral vascular diseaseC ObesityC Other immobilityC OdorC StrokeC OtherDiagnostic StudiesDATERESULTS01/Apr/05C Culture 09/Mar/05MRSAC X-raysOther TreatmentsC DebridementC WhirlpoolC Topical creamsC Special dressingsSigns and SymptomsSigns and symptomsDateSeverity*Change from prior visit**PainRednessWarmthTenderness to nopathyOther*0 none 1 mild 2 moderate 3 severe**0 unchanged 1 resolved 2 worse 3 new 4 unknown/missingCompliments of Mountainside MD Press and Conducting Clinical Research.9

Samples, Forms, and WorksheetsCulturesWere specimens sent for culture?C YesSource of specimenC BloodC PusC Aspirate C OtherC NoC BiopsyC CurettageWas this a deep culture? C Yes C NoIf no, specimen is not acceptable; obtain another sample.Was a Gram stain done? C Yes C NoDid the Gram stain show wbc*? C Yes C NoDid the Gram stain show Gram positive cocci in clumps?If no, patient must be dropped from the study.C YesC NoCulture ResultsAccessionnumberDateSourceResult(use organism code)SiteSensitivity ResultsOrganism 1Organism 2, etc.Bacteria isolatedMRSAE. coliReport sensitivities to thefollowing antibioticsMIC (ug/ml)MIC Rifampin* White blood cells, i.e., signs of infectionThe questions go on and on. This sample of an easy case report form (CRF)is intended just to whet your appetite. Especially on early phase 2 studies, itis helpful to see a sample CRF to assess its complexity before finalizing yourbudget.Compliments of Mountainside MD Press and Conducting Clinical Research.10

Samples, Forms, and WorksheetsConcomitant MedicationsAll medications that the volunteer is taking must be noted so that drug interactionsor changes in lab test results or symptoms can be better evaluated and attributedto a particular medication. Noting the indication will help you recognize gaps inthe volunteer’s history or identify adverse events.Concomitant MedicationsMedicationRoute dateCompliments of Mountainside MD Press and Conducting Clinical Research.11Stopdate