Sponsors and Investigators Flashcards
Adequate Resources
Investigator ensures all persons assisting are informed about protocol, IP, and their duties and functions
A sponsor can transfer any or all of it’s study related duties to a
Contract Research Organization (CRO) if documented in writing, but ensuring oversight as the ultimate responsbility for the quality and integrity resides with the sponsor
Can a sponsor charge for an investigational drug?
Yes – the sponsor can charge for an investigational drug if it meets certain criteria: there’s evidence it provides significantly more clinical benefit than SOC option, demonstrate that the data to be obtained is essential, demonstrate the trial could not be conducted without charging (manufacturing complexity, scarcity of natural resource, large quantity, etc.)
Cover sheet for an IND application
Form 1571
Essential Documents before a trial
- IB (ivestigator & sposnor)
- signed protocol
- amendments
- sample CRFs (case report forms)
- ICF(s)
- subjects documents
- Advertisements (for investigator only)
- FDFs
- Insurance statement
- Signed agreement
- IEC/IRB Approval; member list
- FDA Approval
- CVs
- Lab Values
Essential Documents during a trial
- IB Updates
- Revisions to study documents
- IRB approvals
- Regulatory authority approvals
- new CVs
- Lab value updates
- Monitor visit reports
- Relevant communication
- Signed ICFs (investigator only)
- Source docs
- CRFs
- SAEs
- OSRs
- annual IRB reports
- Subjects screening log
- Code list
- Enrollment log
- IP accountability
- Signature sheets
Essential documents after a trial
- IP accountability
- IP destruction
- Subject ID code (investigator only)
- Audit certificates
- Final Trial close out reports (sponsor only)
- Decoding
- Final IRB reprot (investigator only)
- Clinical study report (investigator only)
Form 1571 Parts
- Name of sponsor (can be individual or company), sponsor address, date of submission, Telephone number
- Name of drug, IND number, IND Type (commercial or research)
- Proposed Indiciation (use for disease type), orphan number if applicable for rare diseasesm SBINED CT code (disease term)
- Phase of Trial
- Cross reference info about drug unless marketed without change to approved packaging
- Serial Number for IND submissions (consecutive), why you are submitting if it is an initial or change
- Digital health technology-collect data from subjects, combination products,justification statement if needed, ex. expanded access, check all that apply to the form,
- Items you are submitting, and CRO
- Person responsibile for monitoring investigators and person reviewing and evaluating information relevant to the safety of the drug
- Sponsor (must be an individual to sign the form), address, email, facsimile (fax) #, For INDs submitted to the Center for Biologics Evaluation and Research (CBER), a specific statement authorizing communication via non-secure email should be included in the cover letter as applicable
- Date sponsor signs, countersigner in the U.S. if person signing is not in the U.S., countersigner email, sponsor & countersigner signature
Form 1572
Statement of Investigator agree to conduct study & comply with sponsor requirements:
* Personally conduct or supervise the investigation according to the protocol
* Inform the subjects that the drugs are being used for investigational purposes and satisfy other requirements for obtaining informed consent
* Maintain complete and accurate records and make the records available for inspection.
Form 1572 Statements
- statement of investigator qualificaitons,
- investigator & sub-Is, only qualified to receive & use the product
- Binding between investigator & FDA
- personally conduct & supervise according to the protocol
- inform subjects drugs are investigational and do informed consent
- maintain complete & accurate records-available for inspection
Form 1571 IND FDA submissions
initial, amendments, new protocols, new side effects
FDA Principal Investigator (PI)
the responsbile leader of a team of individuals conducting a clinical investigation (other members of the team are sub-investigators)
For FDA: Clinical Investigator
- An individual who actually conduct(s) a clinical investigation, under whose immediate direction the drug or biologic is adminstered or dispensed to a subject
FDA
Form 1571
Investigational New Drug Application, coversheet for IND application
How long do investigators need to keep current Financial Disclosure Forms (FDA Form 3455) for?
Before study initiation, during the study, and 1 year after study completion
Investigator
Responsible for the overall conduct of the study at the site, protecting the rights & welfare of human research subjects, ensuring validtiy & intergrity of data collected
Investigator & investigational product
-Investigator is responsible for management, storage, secruity, administration of investigational product
-Must ensure subjects understand how to use & check for compliance
-Product delievery, temp monitoring, invetnory, dispensation, product use by research subject, product storage, return & reconciliation of product to sponsor or disposition & for all other meds used
Investigator Qualifications & Agreements
-education, training, & experience document through cv, training, meeting minutes, or presentations
-demonstrate awareness of GCP & regulatory requirements
-Familiar with protocol, IB, use of IP
Snsure all study team members are qualified, competent, trained, and understand tasks, carefully delegate
Retains overall responsbility, supervise, maintain DOA, delegate after training
Investigator-Initiated Study
-Responsibilities as sponsor
-Study Design, ensuring appropraite institutional, regulatory, and ethics committee approvals
-Study conduct including medical safeguards, record keeping, monitoring, AE reporting, medical supervision, analysis & interpretation of results, communication of results
Investigators should send the Sponsor a new 1572 to submit to the FDA for
-Address change for site or site addition (EMC)
-New Outside Lab facility
Sub-I leaves or joins the study team
PSP or altenative contract
PI should sign to confirm agreemen to follow protocol (protocol signature page)
Sponsor
individual, company, institution, or organization which takes responsibiltiy for the initiation, management, and/or funding of a clinical trial
Sponsor-Investigator
an individual who both initiates and conducts a clinical trial (investigation in U.S.) and under whose immediate direction the investigational product (drug/device in U.S.) is administered, dispensed to, or used by a subject
-obligations of both a sponsor & investigator
ICH
Sponsor Responsibilities
- Implementing and maintaining a quality management system through all stages of the trial proces, risk-based approach
- Implementing and maintaining quality assurance and quality control systems, include SOPs, written, to ensure are conducted in accordance with GCP, and in compliance with legal, ethical, and regulatory requirements
- Designate qualified medical personnel who will advise on medical questions or problems related to the study (medical monitors)
- select investigators qualified by training and experience to properly conduct the study.
CVs, medical licenses and training certificates - ensure the research has sound scientific rationale and principles
- preparation of documents (Investigator’s Brochure, protocol, subject information and consent, case report forms, final report)
- Providing investigator(s) with the necessary information to conduct the study, ensure they are appropriately qualified, trained, understand role, use subject ID codes that are unambiguous that allow identification of all the data reported for each subject
- provide the investigational product(s), as well as information to ensure the safe use of these products, ensuring compliance with labelling, reporting, and recordkeeping requirements, and maintain a system for disposition of unused
- Ensuring all necessary ethics review(s) and approval(s) are obtained
- Providing compensation and indemnity in the event of a study-related injury or death
- Safety Management and Reporting of applicable adverse events, ongoing safety evaluation, setting up a data safety monitoring board (DSMB), sending reports of all serious and unexpected adverse reactions to all investigators and applicable regulatory authorities, preparing periodic safety updates for review by applicable regulatory authorities
- Ensuring data management, record retention, reporting, and generation of study reports
- Ensuring proper monitoring of the study, trained and experienced
- Preparing and submitting clinical trial application(s) and amendment(s) to the appropriate regulatory agencies
