Which of the following statements are contained in ICH E6: GCP

1. In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
2. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding.
3. Care should be taken to choose block lengths that are sufficiently short to limit possible imbalance, but that are long enough to avoid predictability towards the end of the sequence in a block. Investigators and other relevant staff should generally be blind to the block length.
   

Which of the following statements are contained in ICH E6: GCP

1. In conducting a controlled trial, randomised allocation is the preferred means of assuring comparability of test groups and minimising the possibility of selection bias.
2. Methods used to evaluate patient usage of the test drug should be specified in the protocol and the actual usage documented.
3. In general, women of childbearing potential should be using highly effective contraception to participate in clinical trials
   

Which of the following statements are contained in ICH E6: GCP?

1. If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
2. If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority(ies).
3. The minutes of meetings of any data monitoring group and any data reports reviewed at those meetings, particularly a meeting that led to a change in the protocol or early termination of the study, may be helpful and should be provided in appendix.
   

Which of the following statements are contained in ICH E6: GCP?

1. The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
2. The primary variable (target variable, primary endpoint) should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.
3. Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.