Clinical Research Tech New Employee Info

how long are Health Records in Indiana retained?

7 years

How long are VHA documents retained

indefinitely

how long are FDA documents retained?

2 years

how long are HIPPA documents retained?

6 years

Electronic Regulatory Binder set up

*IT will help set up Clinical Research area on drive *create a "studies" folder

Phase 1 clinical trials

1) Healthy Subjects testing Pharmacokenetics and pharmacodynamics 2) Helps identify future patients at risk 3) guides phase 2 planning

Regulatory Binder MUST HAVES

1) signed principal protocol signature page 2)IRB approved ICS with version # and date 3)sponsor progress reports 4)current signed and dated CV - keep expired ones as well 5)FinancialDisclosure Forms (FDF) 6) Clinical Research and Study Training documentation 7)Specimen Tracking Log 8) Serious Adverse Events 9) protocol deviations 10)Clinical Site Monitoring visits log reports

Managing an electronic Regulatory Binder

1)Establish "current" and "archive" folders to manage versions 2)KC IRB is the source of truth 3)Establish a standardized naming convention for each study folder Sponsor-PI-Study Short title Example: Medtronic-Miller-Ablation Device study Name should match the Protocol No. within OnCore (PI) Keep Sponsored and Investigator Initiated Trials (IIR) separated 4)Establish an archive folder when trials are closed

how long are IRB documents retained?

3 years

Best Practice Recommendations for electronic copies

1)Place a paper place holder in the regulatory binder that directs individuals to the electronic location or place a paper holder in one location that includes a list of ALL documents that are stored only in electronic format along with a specific electronic path for each item 2)Limit electronic documents that are: Easily accessible to site staff, auditors, or clinical monitors Electronic location is controlled, regular back ups, and is not in the danger of changing in the future E-mail correspondence Include documentation in the binder that email will be archived to a permanent storage medium and document the easy accessible location

Best Practice Recommendations for paper copies

1)Store items with the newest item within a section at the front of the section 2)Use tab dividers to label the section appropriately

Other Electronic Management Sources

1)all subject visits track on OnCore 2) all finances are tracked on OnCore 3)cardiology research pulled from OnCore 4) Powertrials maintained in Cerner Power Chart 5) Cerner Power Chart access obtained for research monitors 6) Cerner list maintained for study subjects 7) document concent process in EMR/Cerner Power Chart 8) ICS is placed in Cerner Power Chart

Critical Info not kept in Regulatory Binder

1)confidential list of participants enrolled that includes their ID #- should be kept in secure location locked away- usually in subject binders with signed consent forms 2) financial documents stored separately

how long are Global Trail documents retained?

15+ years

CRF

Case Report Form -A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject

Phase 4 clinical trials

Testing that continues after drug has already been approved and gone to market (being sold) to test long term safety smaller than phase 3 studies

FDF

Financial Disclosure Form

IIT

Investigator Initiated Trials

Phase 3 clinical trials

Larger Scale (1000's) efficacy and safety are primary endpoints registration trials need 2 positive trials for approval

Phase 2 clinical trials

Larger number (50-500) of patients with the disease to find dose range based on risk/benefit

Types of CRFs

Paper-worksheet, questionnaires, scales, diaries Electronic Data Capture systems(EDCs)-web based software, RedCap, OnCore Hardware-iPads, sponsor provided computers

Investigator Initiated Trials

Post marketing trials on approved medications for use in off label or exploratory manners Proof of concept studies Not industry designed or sponsored

adverse event

best tool for finding is eyes, ears, and heart

regulatory binder documents may include

variety of logs protocol/amendments sent to IRB Consent versions IRB submissions Drug/Device Accountability 1572 if needed CV's financial disclosures/licenses local lab certificates Serious adverse events /adverse events final CRF

Regulatory Binder

where regulatory documentation related to the study are stored and updated