Polaris

More documents

Recommendations

Info

CompanyTraining Plan FormEmployee:Supervisor/Mentor:TrainingInstructorInstructor’sInitials*DatecompletedEmployee HandbookCompany SOPsDepartmental SOPsProject-Specific SOPsProtocol _________Investigator’s Brochure for _________* Instructor’s initials indicate student has completed that portion of the training plan.Training Plan.doc© 2004 by CRC Press LLC
Page 2:
HANDBOOK OFSOPs FOR GOODCLINICAL PR
Page 10:
About PolarisClinical Research Cons
Page 14:
Table of ContentsMON-001.0MON-002.0
Page 18:
Initial SubIRB MemberMinutes Templa
Page 22:
SOP# MON-001.0CompanyEffective Date
Page 26:
CompanyStandard Operating Procedure
Page 30:
Page 34:
Page 38:
Page 42:
Page 46:
Page 50:
Page 54:
Page 58:
Page 62:
Page 66:
Page 70:
Page 74:
Page 78:
Page 82:
Page 86:
Page 90:
Page 94:
Page 98:
Page 102:
Page 106:
Page 110:
Page 114:
Page 118:
Page 122:
Page 126:
Page 130:
Page 134:
Page 138:
Page 142:
Page 146:
Page 150:
SOP# SITE-001.0CompanyEffective Dat
Page 154:
Page 158:
SOP# SITE-002.0F. Retention of Trai
Page 162:
Page 166:
Page 170:
Page 174:
Page 178:
Page 182:
Page 186:
Page 190:
Page 194:
Page 198:
Page 202:
Page 206:
Page 210:
Page 214:
Page 218:
Page 222:
Page 226:
Page 230:
Page 234:
SOP# SITE-013.0E. Sponsor ContactsC
Page 238:
Page 242:
SOP# SITE-014.0V. AttachmentsNoneCo
Page 246:
SOP# IRB-001.0CompanyEffective Date
Page 250:
Page 254:
Page 258:
Page 262:
Page 266:
Page 270:
Page 274:
Page 278:
Page 282:
Page 286:
Page 290:
Page 294:
Page 298:
Page 302:
Page 306:
Page 310:
Page 314:
Page 318:
Page 322:
CompanyProtocol Amendment FormProto
Page 326:
CompanyCRF Review FormProtocol #: I
Page 330:
CompanyDrug Dispensing LogDrug name
Page 334:
CompanyClinical Trial Materials Dis
Page 338:
CompanyInvestigational Product Rece
Page 342:
CompanyScreening and Enrollment Log
Page 346:
CompanyExpedited Review FormStudy I
Page 350:
CompanySubject Information and Cons
Page 354:
CompanySubject Information and Cons
Page 358:
CompanyStudy Initiation Document Tr
Page 362:
CompanyInitial Submission Form (con
Page 366:
Page 370:
Page 374:
CompanyIRB Membership RosterMultipl
Page 378: CompanyRecommendations (number the
Page 382: CompanyThe meeting adjourned at --:
Page 386: CompanyMaster Subject LogProtocol #
Page 390: CompanyTelephone Contact ReportDate
Page 394: CompanyIRB Progress Report Form (co
Page 398: CompanyStaff Member’s Name(Please
Page 402: CompanyReviewer’s Checklist (cont
Page 406: CompanySerious Adverse Subject Init
Page 418: CompanyStudy Site Personnel Signatu
Page 422: CompanyIRB Study Termination Acknow
Page 426: CompanySummary of SAEsSubjectInitia
Page 432: CompanyEmployeeProject-specific tra
Page 436: CompanyStaff Training Request FormE
Page 440: CompanySite Evaluation Visit Trip R
Page 444: CompanyOverall Assessment (continue
Page 448: CompanyMEETING CONTENTINDICATE WHIC
Page 452: CompanyPeriodic Site Visit Trip Rep
Page 456: CompanySERIOUS ADVERSE EXPERIENCESS
Page 460: CompanyStudy Termination Visit Trip
Page 464: CompanyStudy Drug (continued)Yes No
Page 468: CompanyMeeting with InvestigatorDid
show all

Polaris

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?