SITE START UP AND

MAINTENANCE
By neha dung
SOURCE DOCUMENTS
 Source documentation is the medical record of the subject before, during and after the trial. It is the tool which
confirms the eligibility criteria of the subject in the given trial.
 When we look through source documents I am checking that they follow the principle of ALCOA:
 A-attributable, who wrote this?
 L-legible, can I read this?
 C-contemporaneous, was this recorded at the time of trial conduct or later?
 O-original, is this unaltered or copied?
 A-accurate, is this a correct reflection of the conduct?
 New added “C” is for “Complete”, Which is now ALCOA- C
 Examples of source documents
 Hospital records
 Clinical and office charts
 Laboratory notes
 Memorandum
 Subjects' diaries or evaluation checklists
 Pharmacy dispensing records
 Recorded data from automated instruments
 Copies or transcriptions certified after verification as being accurate copies
 Microfiches
 Photographic negatives, microfilm or magnetic media
 X-rays
 Subject files
 Records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial.
REG. START UP AND MAINTAINCE
 CLIA-  Clinical Laboratory Improvement Amendments. The Centers for Medicaid and
Medicare Services (CMS) regulates laboratory testing through the CLIA certification program.
The objective of CLIA is to ensure the accuracy, reliability and timeliness of patient test results
through quality laboratory standards.
 Either the site should have it’s certification or CLIA waiver.
 IATA – International Air Transport Association.
 For shipping the samples.
 Essential documents
These are those documents that Individually and collectively permit evaluation of both
the conduct of a clinical trial and the quality of the data produced.
Documents from SSV to SIV
SSV(Site Selection Visit)
CDA/NDA(Confidential Disclosure Agreements)
The protocol may have confidential information that the company needs to safeguard. The
mechanism to protect the confidential information is the execution of a Confidential Disclosure
Agreement (CDA).  
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1572 form in Reg. Binder

 Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a
contract between the Principal Investigator (PI) and the FDA. This form contains all details of
the subjects, as well as commitments from the PI.
Protocol
Condensed form of protocol is given to the PI and PI signs the protocol sign page for the sponsor
to know that protocol has been read.
IB (Investigator’s brochure)
The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the
investigational product(s) that are relevant to the study of the product(s) in human subjects.
Financial Disclosure Form
The following financial disclosure guidelines have been developed by the NIDDK to promote fair,
open, and unfettered discussion of important conflict of interest concerns the trial, which aims
to help multicenter study groups ensure that the study are not biased by financial influences. 
IRB approval
It’s a 13 page form for the site approval of a study, which includes the name of PI, certain
questions as requirtment is volunteer or not or the community requirements.
ICF template
Informed consent form created by sponsor and approved by IRB
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CV/MRC of PI(principal Investigator)
This is for the evidence of PI that the person is qualified, experienced and
trained.
GCP certificate
The PI and research participants should be having Good Clinical Practices
Certificate
SIV (Site Initiation Visit)
Regular maintained documents

Delegation of duties log/ delegation of authority logs

List of persons involved in the study at the site level and duties assigned to them
Training log
Training log is filled by the CRA during SIV while the training is given to the
research team and signed by the persons present.
Protocol amendments
A new protocol designed during the study which requires new training and Protocol sign
Page.
ICF amendments
Any ICF amendments should be resigned by the participant else leads to protocol
deviation.
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Deviation log
Any deviation noticed should be on deviation log and sent to IRB
Action taken – CAPA ( Corrective action Preventive action)
 Members in the study are retrained on protocol.
 Take advantage of the latest technology and adopt an electronic CQMS for managing CAPA
and also your trial master file (TMF). 
 The ICH guidelines outline the types of protocol deviations that should be reported as “serious
breaches” and require appropriately serious CAPAs.