Essential documents for the conduct of a clinical trial:

  1. Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
  2. Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor's independent audit function and inspected by the regulatory authority (is) as part of the process to confirm the validity of the trial conduct and the integrity of data collected.
  3. The minimum list of essential documents which has been developed follows. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated: 1) before the clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the trial. A description is given of the purpose of each document, and whether it should be filed in either the investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents, provided the individual elements are readily identifiable.
  4. Trial master files should be established at the beginning of the trial, both at the investigator/institution’s site and at the sponsor's office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.

Clinical trial Protocol 5,6:Clinical trial protocol is a document used to gain confirmation of the trial design by a panel of experts and adherence by all study investigators, even if conducted in various countries. It is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard health of the participants as well as answer specific research questions.A protocol describes what types of people may participate in the trial, the schedule of tests procedures, medications, statistical consideration, organization of the planned trial and dosages, and the length of the study.  The protocol contains a precise study plan for executing the clinical trial, not only to assure safety and health of the trial subjects, but also to provide an exact template for trial conduct by investigators at multiple locations(in a multicentre trial) to perform the study in exactly the someway. This harmonization allows data to be combined collectively as through all investigators were working closely together.

              The protocol also give the study administrators as well as site team of physicians, nurses and clinical administrators a common reference document for site responsibility during the trial. The contents of a trial protocol should generally include the following topics

 General Information:

  1. Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).
  2. Name and address of the sponsor and monitor (if other than the sponsor).
  3. Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor.
  4. Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial.
  5. Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).
  6. Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator). Name(s) and address (as) of the clinical laboratory (is) and other medical and/or technical department(s) and/or institutions involved in the trial.

 Background Information:

i. Name and description of the investigational product(s).

ii. A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that is relevant to the trial.

iii. Summary of the known and potential risks and benefits, if any, to human subjects.

iv. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).

v. A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).

vi. Description of the population to be studied.